Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
Study NCT ID:
NCT04437368
Status:
TERMINATED
Last Update Posted:
2025-09-02
First Post:
2020-06-03
Has Adverse Events:
True
Brief Title:
EXPLORE: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D057092', 'term': 'Geographic Atrophy'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D057088', 'term': 'Anetoderma'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@Novartis.com', 'phone': '+ 1 862 778 8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events are reported from randomization up to end of study, for a maximum timeframe of approximately 96 weeks.', 'description': 'Full Analysis Set - all randomized participants. Part 1 enrolled subjects with Complement factor I (CFI) rare variant; Part 2 enrolled subjects regardless of genotype (i.e., CFI-rare and CFI-non-rare variants) . Part 1 and Part 2 are not defined in the protocol as distinct arms. Since there were no safety concerns, it was determined that there was no scientific value in reporting safety results by part / genotype, but by treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'GT005 Low Dose [2E10 vg]', 'description': 'GT005 Low Dose \\[2E10 vg\\]', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 19, 'seriousNumAtRisk': 52, 'deathsNumAffected': 3, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'GT005 High Dose [2E11 vg]', 'description': 'GT005 High dose \\[2E11 vg\\]', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Untreated Control', 'description': 'Subjects allocated to the untreated control group did not receive any treatment.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 16, 'seriousNumAtRisk': 37, 'deathsNumAffected': 2, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Overall', 'description': 'Overall', 'otherNumAtRisk': 98, 'deathsNumAtRisk': 98, 'otherNumAffected': 44, 'seriousNumAtRisk': 98, 'deathsNumAffected': 5, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Hypochromic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Anterior chamber cell - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Anterior chamber flare - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Blepharitis - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Blepharitis - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Cataract - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Cataract - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Cataract nuclear - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Choroidal detachment - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Choroidal neovascularisation - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Conjunctival haemorrhage - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Conjunctival hyperaemia - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Conjunctivitis allergic - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Conjunctivitis allergic - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Dry eye - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Dry eye - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Eye pain - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Eye pruritus - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Eye pruritus - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Hypotony maculopathy - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Iridocyclitis - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Iritis - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Keratitis - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Lacrimation increased - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Macular hole - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Meibomian gland dysfunction - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Meibomian gland dysfunction - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Metamorphopsia - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Ocular hypertension - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Open angle glaucoma - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Open angle glaucoma - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Photophobia - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Photopsia - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Photopsia - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Posterior capsule opacification - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Posterior capsule opacification - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Punctate keratitis - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Retinal degeneration - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Retinal depigmentation - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Retinal haemorrhage - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Retinal haemorrhage - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 98, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Retinal oedema - Fellow eye', 'stats': 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Low Dose \\[2E10 vg\\]'}, {'id': 'OG001', 'title': 'GT005 High Dose [2E11 vg]', 'description': 'GT005 High Dose \\[2E11 vg\\]'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Subjects allocated to the untreated control group did not receive any treatment.'}], 'classes': [{'title': 'Part 1 Week 72 (n=5,7,9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.643', 'spread': '0.9725', 'groupId': 'OG000'}, {'value': '3.149', 'spread': '0.9150', 'groupId': 'OG001'}, {'value': '1.875', 'spread': '0.8273', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 Week 96 (n=6,8,7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.837', 'spread': '1.0712', 'groupId': 'OG000'}, {'value': '4.074', 'spread': '1.0305', 'groupId': 'OG001'}, {'value': '2.796', 'spread': '0.9240', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.769', 'ciLowerLimit': '-0.441', 'ciUpperLimit': '3.979', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.2808', 'groupDescription': 'Week 72', 'statisticalMethod': 'mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.274', 'ciLowerLimit': '-0.863', 'ciUpperLimit': '3.412', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.2349', 'groupDescription': 'Week 72', 'statisticalMethod': 'mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.041', 'ciLowerLimit': '-0.386', 'ciUpperLimit': '4.468', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.4177', 'groupDescription': 'Week 96', 'statisticalMethod': 'mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.278', 'ciLowerLimit': '-1.099', 'ciUpperLimit': '3.655', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.3857', 'groupDescription': 'Week 96', 'statisticalMethod': 'mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 72 and 96', 'description': 'The change from baseline to Week 48 in GA area as measured by fundus autofluorescence (FAF)', 'unitOfMeasure': 'mm2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - for randomized participants with a valid measurement without a protocol deviation with impact.'}, {'type': 'SECONDARY', 'title': 'Summary of Adverse Events - Parts 1 and 2 Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GT005 Low Dose [2E10 vg]', 'description': 'GT005 Low Dose \\[2E10 vg\\]'}, {'id': 'OG001', 'title': 'GT005 High Dose [2E11 vg]', 'description': 'GT005 High Dose \\[2E11 vg\\]'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Subjects allocated to the untreated control group did not receive any treatment.'}], 'classes': [{'title': 'Subjects with at least one ocular adverse event for the study eye', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least one ocular adverse event for the fellow eye', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least one non-ocular adverse event', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least one ocular adverse event related to study treatment for the study eye', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least one non-ocular adverse event related to study treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least one ocular adverse event related to surgical procedure for the study eye', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least one non-ocular adverse event related to surgical procedure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least one ocular adverse event related to study procedure for the study eye', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least one non-ocular adverse event related to study procedure', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least one ocular adverse event leading to study discontinuation for the study eye', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least one non-ocular adverse event leading to study discontinuation', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least one ocular adverse event of special interest for the study eye', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least one ocular adverse event of special interest for the fellow eye', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least one ocular serious adverse event (SAE) for the study eye', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least one ocular serious adverse event for the fellow eye', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least one non-ocular serious adverse event', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least one ocular serious adverse event related to study treatment for the study eye', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least one non-ocular serious adverse event related to study treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least 1 ocular SAE related to surgical procedure - study eye', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least one non-ocular serious adverse event related to surgical procedure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least one ocular serious adverse event related to study procedure for the study eye', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least one non-ocular serious adverse event related to study procedure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least 1 ocular SAE event leading to study discontinuation- study eye', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Subjects with at least one non-ocular serious adverse event leading to study discontinuation', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Adverse events are reported from randomization up to end of study, for a maximum timeframe of approximately 96 weeks.', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject.\n\nA TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - all randomized participants. Part 1 enrolled subjects with Complement factor I (CFI) rare variant; Part 2 enrolled subjects regardless of genotype (i.e., CFI-rare and CFI-non-rare variants) . Part 1 and Part 2 are not defined in the protocol as distinct arms. Since there were no safety concerns, it was determined that there was no scientific value in reporting safety results by part / genotype, but by treatment.'}, {'type': 'SECONDARY', 'title': 'Ocular Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye - Parts 1 and 2 Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GT005 Low Dose [2E10 vg]', 'description': 'GT005 Low Dose \\[2E10 vg\\]'}, {'id': 'OG001', 'title': 'GT005 High Dose [2E11 vg]', 'description': 'GT005 High Dose \\[2E11 vg\\]'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Subjects allocated to the untreated control group did not receive any treatment.'}], 'classes': [{'title': 'Subjects with at least one event', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Eye disorders', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': '-Retinal pigmentation', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Conjunctival haemorrhage', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Cataract', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': '-Cataract nuclear', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Eye pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Retinal haemorrhage', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Anterior chamber cell', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Blepharitis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Conjunctivitis allergic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Anterior chamber flare', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Choroidal detachment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Conjunctival hyperaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Dry eye', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Eye pruritus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': '-Hypotony maculopathy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Iridocyclitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Iritis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Keratitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Lacrimation increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Macular hole', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Meibomian gland dysfunction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Metamorphopsia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Ocular hypertension', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Open angle glaucoma', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Photophobia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Photopsia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Posterior capsule opacification', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': '-Punctate keratitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Retinal depigmentation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Visual acuity reduced', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Visual impairment', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Visual snow syndrome', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Vitreous floaters', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Vitreous haemorrhage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Injury, poisoning and procedural complications', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Post procedural discomfort', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Procedural pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Suture related complication', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Investigations', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Intraocular pressure increased', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Skin and subcutaneous tissue disorders', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Telangiectasia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Adverse events are reported from randomization up to end of study, for a maximum timeframe of approximately 96 weeks.', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject.\n\nA TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.\n\nSystem organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - all randomized participants. Part 1 enrolled subjects with Complement factor I (CFI) rare variant; Part 2 enrolled subjects regardless of genotype (i.e., CFI-rare and CFI-non-rare variants) . Part 1 and Part 2 are not defined in the protocol as distinct arms. Since there were no safety concerns, it was determined that there was no scientific value in reporting safety results by part / genotype, but by treatment.'}, {'type': 'SECONDARY', 'title': 'Non-ocular Adverse Events - Summary - Parts 1 and 2 Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GT005 Low Dose [2E10 vg]', 'description': 'GT005 Low Dose \\[2E10 vg\\]'}, {'id': 'OG001', 'title': 'GT005 High Dose [2E11 vg]', 'description': 'GT005 High Dose \\[2E11 vg\\]'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Subjects allocated to the untreated control group did not receive any treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Adverse events are reported from randomization up to end of study, for a maximum timeframe of approximately 96 weeks.', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject.\n\nA TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - all randomized participants. Part 1 enrolled subjects with Complement factor I (CFI) rare variant; Part 2 enrolled subjects regardless of genotype (i.e., CFI-rare and CFI-non-rare variants) . Part 1 and Part 2 are not defined in the protocol as distinct arms. Since there were no safety concerns, it was determined that there was no scientific value in reporting safety results by part / genotype, but by treatment.'}, {'type': 'SECONDARY', 'title': 'Change in GA Morphology From Baseline to Week 96 on Colour Fundus Photography (CFP) - Number of Participants With Increase in Fundus Autofluorescence (FAF) - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GT005 Low Dose [2E10 vg]', 'description': 'GT005 Low Dose \\[2E10 vg\\]'}, {'id': 'OG001', 'title': 'GT005 High Dose [2E11 vg]', 'description': 'GT005 High Dose \\[2E11 vg\\]'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Subjects allocated to the untreated control group did not receive any treatment.'}], 'classes': [{'title': 'Part 1 Week 5 (n= 0,2,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Part 1 Week 12 (n=9,8,12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 Week 24 (n=9,7,10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 Week 36 (n=6,7,10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 Week 48 (n=5,8,10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 Week 72 (n=5,8,9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 Week 96 (n=6,8,7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Weeks 5,12,24,36,48,72,96', 'description': 'Change in GA morphology on multimodal imaging through Week 96.\n\nFAF images at Week 5 were introduced via a protocol amendment after most participants had already completed Week 5; therefore, only a minimal number of patients had FAF images taken at Week 5 for Part 1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - for randomized participants with a valid measurement without a protocol deviation with impact.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 48 in GA Morphology on Colour Fundus Photography (CFP) - Number of Participants With Increase in Fundus Autofluorescence - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GT005 Low Dose [2E10 vg]', 'description': 'GT005 Low Dose \\[2E10 vg\\]'}, {'id': 'OG001', 'title': 'GT005 High Dose [2E11 vg]', 'description': 'GT005 High Dose \\[2E11 vg\\]'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Subjects allocated to the untreated control group did not receive any treatment.'}], 'classes': [{'title': 'Part 2 Week 5 (n= 16,0, 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Part 2 Week 12 (n=17,0,20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'Part 2 Week 24 (n=17,0,11)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Part 2 Week 36 (n=14,0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Part 2 Week 48 (n=5,0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Weeks 5,12,24,36,48', 'description': 'Change in GA morphology on multimodal imaging through Week 48.\n\nFor the untreated control group, there were no protocol-specified visits for Weeks 5 and 8.\n\nThe untreated control participants were immediately discontinued from the study when the study was early terminated; therefore Week 36 and 48 data in part 2 were not applicable for these the untreated control group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - for randomized participants with a valid measurement without a protocol deviation with impact.'}, {'type': 'SECONDARY', 'title': 'Change in Best Corrected Visual Acuity (BCVA) Score From Baseline Through Week 96 Via the Early Treatment for Diabetic Retinopathy (ETDRS) Chart - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GT005 Low Dose [2E10 vg]', 'description': 'GT005 Low Dose \\[2E10 vg\\]'}, {'id': 'OG001', 'title': 'GT005 High Dose [2E11 vg]', 'description': 'GT005 High Dose \\[2E11 vg\\]'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Subjects allocated to the untreated control group did not receive any treatment.'}], 'classes': [{'title': 'Part 1 - Week 1 (n=9,9,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.7', 'spread': '4.04', 'groupId': 'OG000'}, {'value': '-5.2', 'spread': '4.27', 'groupId': 'OG001'}]}]}, {'title': 'Part 1 - Week 5 (n=8,9,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '4.08', 'groupId': 'OG000'}, {'value': '-7.6', 'spread': '4.26', 'groupId': 'OG001'}]}]}, {'title': 'Part 1 - Week 8 (n=9,9,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '4.03', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '4.23', 'groupId': 'OG001'}]}]}, {'title': 'Part 1 - Week 12 (N=9,9,12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '4.03', 'groupId': 'OG000'}, {'value': '-7.5', 'spread': '4.18', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '3.81', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 - Week 24 (n=9,9,10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.6', 'spread': '4.03', 'groupId': 'OG000'}, {'value': '-12.0', 'spread': '4.18', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '3.87', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 - Week 36 (n=8,8,10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-10.0', 'spread': '4.10', 'groupId': 'OG000'}, {'value': '-12.9', 'spread': '4.28', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '3.89', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 - Week 48 (n=5,8,10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-8.6', 'spread': '4.52', 'groupId': 'OG000'}, {'value': '-13.3', 'spread': '4.32', 'groupId': 'OG001'}, {'value': '-5.7', 'spread': '3.91', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 - Week 72 (n=5,8,10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.3', 'spread': '4.56', 'groupId': 'OG000'}, {'value': '-9.6', 'spread': '4.34', 'groupId': 'OG001'}, {'value': '-8.9', 'spread': '3.94', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 - Week 96 (n=6,8,7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.5', 'spread': '4.50', 'groupId': 'OG000'}, {'value': '-11.0', 'spread': '4.33', 'groupId': 'OG001'}, {'value': '-7.9', 'spread': '4.30', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.1', 'ciLowerLimit': '-10.3', 'ciUpperLimit': '8.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.49', 'groupDescription': 'Week 12', 'statisticalMethod': 'mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-6.3', 'ciLowerLimit': '-16.3', 'ciUpperLimit': '3.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.96', 'groupDescription': 'Week 12', 'statisticalMethod': 'mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-5.2', 'ciLowerLimit': '-14.5', 'ciUpperLimit': '4.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.54', 'groupDescription': 'Week 24', 'statisticalMethod': 'mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-11.7', 'ciLowerLimit': '-21.7', 'ciUpperLimit': '-1.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.00', 'groupDescription': 'Week 24', 'statisticalMethod': 'mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-9.0', 'ciLowerLimit': '-18.4', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.63', 'groupDescription': 'Week 36', 'statisticalMethod': 'mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-11.9', 'ciLowerLimit': '-22.1', 'ciUpperLimit': '-1.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.08', 'groupDescription': 'Week 36', 'statisticalMethod': 'mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-2.9', 'ciLowerLimit': '-12.7', 'ciUpperLimit': '6.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.88', 'groupDescription': 'Week 48', 'statisticalMethod': 'mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-7.6', 'ciLowerLimit': '-17.9', 'ciUpperLimit': '2.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.14', 'groupDescription': 'Week 48', 'statisticalMethod': 'mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.6', 'ciLowerLimit': '-7.4', 'ciUpperLimit': '12.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.96', 'groupDescription': 'Week 72', 'statisticalMethod': 'mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.7', 'ciLowerLimit': '-11.1', 'ciUpperLimit': '9.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.18', 'groupDescription': 'Week 72', 'statisticalMethod': 'mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.4', 'ciLowerLimit': '-8.7', 'ciUpperLimit': '11.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.07', 'groupDescription': 'Week 96', 'statisticalMethod': 'mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-3.0', 'ciLowerLimit': '-13.8', 'ciUpperLimit': '7.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.47', 'groupDescription': 'Week 96', 'statisticalMethod': 'mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 1, 5, 8, 12, 24, 36, 48, 72 and 96', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.\n\nFor the untreated control group, there were no protocol-specified visits for Weeks 1, 5 and 8.', 'unitOfMeasure': 'Letters read', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - for randomized participants with a valid measurement without a protocol deviation with impact.'}, {'type': 'SECONDARY', 'title': 'Change in Low Luminance Difference (LLD) Letter Count From Baseline at Weeks 12, 24, 36, 48, 72 and 96, Via Early Treatment for Diabetic Retinopathy (ETDRS) Chart - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GT005 Low Dose [2E10 vg]', 'description': 'GT005 Low Dose \\[2E10 vg\\]'}, {'id': 'OG001', 'title': 'GT005 High Dose [2E11 vg]', 'description': 'GT005 High Dose \\[2E11 vg\\]'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Subjects allocated to the untreated control group did not receive any treatment.'}], 'classes': [{'title': 'Part 1 - Week 12 (N=9,9,12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '9.06', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '22.49', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '7.21', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 - Week 24 (n=9,9,10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '8.40', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '24.81', 'groupId': 'OG001'}, {'value': '-2.9', 'spread': '7.68', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 - Week 36 (n=8,8,10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '15.65', 'groupId': 'OG000'}, {'value': '-7.5', 'spread': '19.41', 'groupId': 'OG001'}, {'value': '-4.0', 'spread': '12.51', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 - Week 48 (n=5,8,10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '6.96', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '26.25', 'groupId': 'OG001'}, {'value': '-6.2', 'spread': '19.99', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 - Week 72 (n=5,8,10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '7.57', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '32.24', 'groupId': 'OG001'}, {'value': '-6.6', 'spread': '21.15', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 - Week 96 (n=6,8,6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '8.47', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '29.17', 'groupId': 'OG001'}, {'value': '-10.5', 'spread': '27.41', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72 and 96', 'description': 'LLD was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nThe test was to be performed after BCVA testing, prior to pupil dilation, and distance refraction was to be carried out before Low Luminance Visual Acuity (LLVA) was measured.\n\nLLVA was to be measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the subject read the normally illuminated ETDRS chart. The LLD was calculated as the difference between BCVA and LLVA.\n\nInitially, letters were to be read at a distance of 4 metres from the chart. If \\<20 letters were read at 4 metres, testing at 1 metre should have been performed. LLD was to be reported as number of letters read correctly by the subject.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.', 'unitOfMeasure': 'Letters read', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - for randomized participants with a valid measurement without a protocol deviation with impact.'}, {'type': 'SECONDARY', 'title': 'Change in Low Luminance Difference (LLD) Letter Count From Baseline at Weeks 12, 24, 36, and 48, Via Early Treatment for Diabetic Retinopathy (ETDRS) Chart - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GT005 Low Dose [2E10 vg]', 'description': 'GT005 Low Dose \\[2E10 vg\\]'}, {'id': 'OG001', 'title': 'GT005 High Dose [2E11 vg]', 'description': 'GT005 High Dose \\[2E11 vg\\]'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Subjects allocated to the untreated control group did not receive any treatment.'}], 'classes': [{'title': 'Part 2 - Week 12 (N=18,0,20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '10.83', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '11.76', 'groupId': 'OG002'}]}]}, {'title': 'Part 2 - Week 24 (n=17,0,10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '9.98', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '20.13', 'groupId': 'OG002'}]}]}, {'title': 'Part 2 - Week 36 (n=14,0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '11.77', 'groupId': 'OG000'}]}]}, {'title': 'Part 2 - Week 48 (n=5,0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '4.32', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12, 24, 36, and 48', 'description': 'LLD was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nThe test was to be performed after BCVA testing, prior to pupil dilation, and distance refraction was to be carried out before Low Luminance Visual Acuity (LLVA) was measured.\n\nLLVA was to be measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the subject read the normally illuminated ETDRS chart. The LLD was calculated as the difference between BCVA and LLVA.\n\nInitially, letters were to be read at a distance of 4 metres from the chart. If \\<20 letters were read at 4 metres, testing at 1 metre should have been performed. LLD was to be reported as number of letters read correctly by the subject.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.', 'unitOfMeasure': 'Letters read', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - for randomized participants with a valid measurement without a protocol deviation with impact. The untreated control participants were immediately discontinued from the study when the study was early terminated; therefore Week 36 and 48 data in part 2 were not applicable for these the untreated control group.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Weeks 24, 36, 48, 72 and 96 in Reading Performance, Measured as the Maximum Reading Speed (Words Per Minute), as Assessed by Minnesota Low-vision Reading Test (MNRead) Chart - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GT005 Low Dose [2E10 vg]', 'description': 'GT005 Low Dose \\[2E10 vg\\]'}, {'id': 'OG001', 'title': 'GT005 High Dose [2E11 vg]', 'description': 'GT005 High Dose \\[2E11 vg\\]'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Subjects allocated to the untreated control group did not receive any treatment.'}], 'classes': [{'title': 'Part 1 - Week 24 (n=9,8,9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.384', 'spread': '74.7769', 'groupId': 'OG000'}, {'value': '-36.154', 'spread': '40.3322', 'groupId': 'OG001'}, {'value': '-7.837', 'spread': '21.8918', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 - Week 36 (n=7,7,8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-15.048', 'spread': '33.0479', 'groupId': 'OG000'}, {'value': '-34.653', 'spread': '27.2693', 'groupId': 'OG001'}, {'value': '-15.245', 'spread': '22.0983', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 - Week 48 (n=4,7,9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.397', 'spread': '11.8698', 'groupId': 'OG000'}, {'value': '-36.285', 'spread': '40.0938', 'groupId': 'OG001'}, {'value': '-6.837', 'spread': '31.6162', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 - Week 72 (n=5,7,9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-20.796', 'spread': '42.2571', 'groupId': 'OG000'}, {'value': '-44.913', 'spread': '46.7594', 'groupId': 'OG001'}, {'value': '-15.429', 'spread': '30.1012', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 - Week 96 (n=6,5,5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.802', 'spread': '32.1161', 'groupId': 'OG000'}, {'value': '-32.266', 'spread': '36.9172', 'groupId': 'OG001'}, {'value': '-21.602', 'spread': '26.0643', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 24, 36, 48, 72 and 96', 'description': 'The maximum reading speed (MRS) represents the highest reading speed an individual can achieve when print size is not a limiting factor. Essentially, it measures how quickly a person can read text when the print is large enough to be easily readable.\n\nA higher count represents better visual functioning.', 'unitOfMeasure': 'Words read per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - for randomized participants with a valid measurement without a protocol deviation with impact.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Weeks 24, 36 and 48 in Reading Performance, Measured as the Maximum Reading Speed (Words Per Minute), as Assessed by Minnesota Low-vision Reading Test (MNRead) Chart - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GT005 Low Dose [2E10 vg]', 'description': 'GT005 Low Dose \\[2E10 vg\\]'}, {'id': 'OG001', 'title': 'GT005 High Dose [2E11 vg]', 'description': 'GT005 High Dose \\[2E11 vg\\]'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Subjects allocated to the untreated control group did not receive any treatment.'}], 'classes': [{'title': 'Part 2 - Week 24 (n=16,0,10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.581', 'spread': '78.2848', 'groupId': 'OG000'}, {'value': '-30.707', 'spread': '27.3225', 'groupId': 'OG002'}]}]}, {'title': 'Part 2 - Week 36 (n=14,0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.812', 'spread': '94.4255', 'groupId': 'OG000'}]}]}, {'title': 'Part 2 - Week 48 (n=5,0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-28.111', 'spread': '38.6209', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 24, 36 and 48', 'description': 'A higher count represents better visual functioning.\n\nThe untreated control participants were immediately discontinued from the study when the study was early terminated; therefore Week 36 and 48 data in part 2 were not applicable for these the untreated control group.', 'unitOfMeasure': 'Words read per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - for randomized participants with a valid measurement without a protocol deviation with impact.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Weeks 24, 36, 48, 72 and 96 in Functional Reading Independence (FRI) Index - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GT005 Low Dose [2E10 vg]', 'description': 'GT005 Low Dose \\[2E10 vg\\]'}, {'id': 'OG001', 'title': 'GT005 High Dose [2E11 vg]', 'description': 'GT005 High Dose \\[2E11 vg\\]'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Subjects allocated to the untreated control group did not receive any treatment.'}], 'classes': [{'title': 'Part 1 - Week 24 (n=9,8,10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '3.57', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '2.55', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '4.06', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 - Week 36 (n=8,5,10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '4.24', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '4.10', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '4.72', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 - Week 48 (n=6,7,10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '2.43', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '7.69', 'groupId': 'OG001'}, {'value': '-3.4', 'spread': '4.38', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 - Week 72 (n=5,7,10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.8', 'spread': '4.60', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '3.41', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '4.35', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 - Week 96 (n=6,6,7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '5.79', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '3.29', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '5.53', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 24, 36, 48, 72 and 96', 'description': 'The FRI index is a patient-reported outcome measure developed specifically for use in GA patients. The FRI index evaluates the level of independence subjects have in performing everyday activities that require reading, such as writing a cheque or reading a prescription.\n\nScores derived from the index range from 1 (unable to do) to 4 (total independence).\n\nA higher score represents better visual functioning.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - for randomized participants with a valid measurement without a protocol deviation with impact.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Weeks 24, 36 and 48 in Functional Reading Independence (FRI) Index - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GT005 Low Dose [2E10 vg]', 'description': 'GT005 Low Dose \\[2E10 vg\\]'}, {'id': 'OG001', 'title': 'GT005 High Dose [2E11 vg]', 'description': 'GT005 High Dose \\[2E11 vg\\]'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Subjects allocated to the untreated control group did not receive any treatment.'}], 'classes': [{'title': 'Part 2 - Week 24 (n=17,0,9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '6.86', 'groupId': 'OG002'}]}]}, {'title': 'Part 2 - Week 36 (n=14,0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '3.83', 'groupId': 'OG000'}]}]}, {'title': 'Part 2 - Week 48 (n=5,0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '5.13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 24, 36 and 48', 'description': 'The FRI index is a patient-reported outcome measure developed specifically for use in GA patients. The FRI index evaluates the level of independence subjects have in performing everyday activities that require reading, such as writing a cheque or reading a prescription.\n\nScores derived from the index range from 1 (unable to do) to 4 (total independence).\n\nA higher score represents better visual functioning.\n\nThe untreated control participants were immediately discontinued from the study when the study was early terminated; therefore Week 36 and 48 data in part 2 were not applicable for these the untreated control group.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - for randomized participants with a valid measurement without a protocol deviation with impact.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Weeks 24, 36, 48, 72 and 96 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Composite Score - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GT005 Low Dose [2E10 vg]', 'description': 'GT005 Low Dose \\[2E10 vg\\]'}, {'id': 'OG001', 'title': 'GT005 High Dose [2E11 vg]', 'description': 'GT005 High Dose \\[2E11 vg\\]'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Subjects allocated to the untreated control group did not receive any treatment.'}], 'classes': [{'title': 'Part 1 - Week 24 (n=9,9,10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.312', 'spread': '5.7079', 'groupId': 'OG000'}, {'value': '-3.755', 'spread': '7.4470', 'groupId': 'OG001'}, {'value': '-7.304', 'spread': '12.5136', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 - Week 36 (n=8,6,10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.400', 'spread': '11.1307', 'groupId': 'OG000'}, {'value': '1.960', 'spread': '9.0113', 'groupId': 'OG001'}, {'value': '-4.706', 'spread': '11.8617', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 - Week 48 (n=6,8,10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.439', 'spread': '24.2128', 'groupId': 'OG000'}, {'value': '-6.810', 'spread': '11.5980', 'groupId': 'OG001'}, {'value': '-4.091', 'spread': '15.3598', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 - Week 72 (n=5,8,10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-8.698', 'spread': '22.1289', 'groupId': 'OG000'}, {'value': '-3.332', 'spread': '8.1470', 'groupId': 'OG001'}, {'value': '-3.826', 'spread': '11.0029', 'groupId': 'OG002'}]}]}, {'title': 'Part 1 - Week 96 (n=6,7,7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-10.352', 'spread': '23.9470', 'groupId': 'OG000'}, {'value': '0.171', 'spread': '11.3543', 'groupId': 'OG001'}, {'value': '-10.700', 'spread': '11.6900', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 24, 36, 48, 72 and 96', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - for randomized participants with a valid measurement without a protocol deviation with impact.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Weeks 24, 36 and 48 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Composite Score - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'GT005 Low Dose [2E10 vg]', 'description': 'GT005 Low Dose \\[2E10 vg\\]'}, {'id': 'OG001', 'title': 'GT005 High Dose [2E11 vg]', 'description': 'GT005 High Dose \\[2E11 vg\\]'}, {'id': 'OG002', 'title': 'Untreated Control', 'description': 'Subjects allocated to the untreated control group did not receive any treatment.'}], 'classes': [{'title': 'Part 2 - Week 24 (n=17,0,8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.034', 'spread': '6.8881', 'groupId': 'OG000'}, {'value': '-3.070', 'spread': '7.4251', 'groupId': 'OG002'}]}]}, {'title': 'Part 2 - Week 36 (n=14,0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.733', 'spread': '7.9219', 'groupId': 'OG000'}]}]}, {'title': 'Part 2 - Week 48 (n=5,0,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.530', 'spread': '6.9722', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 24, 36, and 48', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.\n\nThe untreated control participants were immediately discontinued from the study when the study was early terminated; therefore Week 36 and 48 data in part 2 were not applicable for these the untreated control group.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - for randomized participants with a valid measurement without a protocol deviation with impact.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GT005 Low Dose [2E10 vg]', 'description': 'GT005 Low Dose \\[2E10 vg\\]'}, {'id': 'FG001', 'title': 'GT005 High Dose [2E11 vg]', 'description': 'GT005 High Dose \\[2E11 vg\\]'}, {'id': 'FG002', 'title': 'Untreated Control', 'description': 'Subjects allocated to the untreated control group did not receive any treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '37'}]}, {'type': 'Randomized Part 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Randomized Part 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '23'}]}, {'type': 'Randomized and Treated Part 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Randomized and Treated Part 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '25'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Sponsor instructions', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This was a randomized, controlled study designed to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with GA secondary to AMD.\n\nThis was a study conducted in 3 treatment arms (GT005 low dose, GT005 high dose, and an untreated control group) and in 2 parts (Part 1 enrolled subjects with Complement factor I (CFI) rare variant; Part 2 enrolled subjects regardless of genotype (i.e., CFI-rare and CFI-non-rare variants));', 'preAssignmentDetails': 'The parts were determined by genotype and not treatment. Because genotype may influence disease progression, these parts were considered in the analysis of the efficacy endpoints only, but not safety, and not demographics, as pre-specified in the SAP and protocol.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'GT005 Low Dose [2E10 vg]', 'description': 'GT005 Low Dose \\[2E10 vg\\]'}, {'id': 'BG001', 'title': 'GT005 High Dose [2E11 vg]', 'description': 'GT005 High Dose \\[2E11 vg\\]'}, {'id': 'BG002', 'title': 'Untreated Control', 'description': 'Subjects allocated to the untreated control group did not receive any treatment.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '76.8', 'spread': '7.33', 'groupId': 'BG000'}, {'value': '72.7', 'spread': '8.96', 'groupId': 'BG001'}, {'value': '75.2', 'spread': '7.07', 'groupId': 'BG002'}, {'value': '75.8', 'spread': '7.41', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS) as described in the study protocol, which included all participants who were randomized to GT005 or untreated control.\n\nBecause genotype may influence disease progression, these parts were considered in the analysis of the efficacy endpoints only, but not safety and not demographics, per the SAP and protocol.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-06', 'size': 8221819, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-07T16:29', 'hasProtocol': True}, {'date': '2024-06-13', 'size': 2781656, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-07T16:29', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The overall objectives of the study are to evaluate the safety and efficacy (anatomical and functional visual outcomes) of two doses of GT005 in genetically defined subjects with GA due to AMD.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a Phase 2, outcomes assessor-masked multicentre, randomised study to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with GA secondary to AMD.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'whyStopped': 'Terminated for interim analysis demonstrating futility (trial highly unlikely to meet efficacy outcome). The trial is not ending early because of medical problems or concerns.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2020-06-03', 'resultsFirstSubmitDate': '2025-03-07', 'studyFirstSubmitQcDate': '2020-06-17', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-07-24', 'studyFirstPostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Change From Baseline to Week 48 in Geographic Atrophy (GA) - Part 1', 'timeFrame': 'Baseline, Weeks 12, 24, 36, and 48', 'description': 'The change from baseline to Week 48 in GA area as measured by fundus autofluorescence (FAF)'}], 'secondaryOutcomes': [{'measure': 'The Change From Baseline in Geographic Atrophy (GA) at Week 72 and Week 96 - Part 1', 'timeFrame': 'Baseline, Weeks 72 and 96', 'description': 'The change from baseline to Week 48 in GA area as measured by fundus autofluorescence (FAF)'}, {'measure': 'Summary of Adverse Events - Parts 1 and 2 Combined', 'timeFrame': 'Adverse events are reported from randomization up to end of study, for a maximum timeframe of approximately 96 weeks.', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject.\n\nA TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.'}, {'measure': 'Ocular Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye - Parts 1 and 2 Combined', 'timeFrame': 'Adverse events are reported from randomization up to end of study, for a maximum timeframe of approximately 96 weeks.', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject.\n\nA TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.\n\nSystem organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class.'}, {'measure': 'Non-ocular Adverse Events - Summary - Parts 1 and 2 Combined', 'timeFrame': 'Adverse events are reported from randomization up to end of study, for a maximum timeframe of approximately 96 weeks.', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a subject or clinical investigation subject.\n\nA TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.'}, {'measure': 'Change in GA Morphology From Baseline to Week 96 on Colour Fundus Photography (CFP) - Number of Participants With Increase in Fundus Autofluorescence (FAF) - Part 1', 'timeFrame': 'Baseline, Weeks 5,12,24,36,48,72,96', 'description': 'Change in GA morphology on multimodal imaging through Week 96.\n\nFAF images at Week 5 were introduced via a protocol amendment after most participants had already completed Week 5; therefore, only a minimal number of patients had FAF images taken at Week 5 for Part 1.'}, {'measure': 'Change From Baseline to Week 48 in GA Morphology on Colour Fundus Photography (CFP) - Number of Participants With Increase in Fundus Autofluorescence - Part 2', 'timeFrame': 'Baseline, Weeks 5,12,24,36,48', 'description': 'Change in GA morphology on multimodal imaging through Week 48.\n\nFor the untreated control group, there were no protocol-specified visits for Weeks 5 and 8.\n\nThe untreated control participants were immediately discontinued from the study when the study was early terminated; therefore Week 36 and 48 data in part 2 were not applicable for these the untreated control group.'}, {'measure': 'Change in Best Corrected Visual Acuity (BCVA) Score From Baseline Through Week 96 Via the Early Treatment for Diabetic Retinopathy (ETDRS) Chart - Part 1', 'timeFrame': 'Baseline, Weeks 1, 5, 8, 12, 24, 36, 48, 72 and 96', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.\n\nFor the untreated control group, there were no protocol-specified visits for Weeks 1, 5 and 8.'}, {'measure': 'Change in Low Luminance Difference (LLD) Letter Count From Baseline at Weeks 12, 24, 36, 48, 72 and 96, Via Early Treatment for Diabetic Retinopathy (ETDRS) Chart - Part 1', 'timeFrame': 'Baseline, Weeks 12, 24, 36, 48, 72 and 96', 'description': 'LLD was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nThe test was to be performed after BCVA testing, prior to pupil dilation, and distance refraction was to be carried out before Low Luminance Visual Acuity (LLVA) was measured.\n\nLLVA was to be measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the subject read the normally illuminated ETDRS chart. The LLD was calculated as the difference between BCVA and LLVA.\n\nInitially, letters were to be read at a distance of 4 metres from the chart. If \\<20 letters were read at 4 metres, testing at 1 metre should have been performed. LLD was to be reported as number of letters read correctly by the subject.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.'}, {'measure': 'Change in Low Luminance Difference (LLD) Letter Count From Baseline at Weeks 12, 24, 36, and 48, Via Early Treatment for Diabetic Retinopathy (ETDRS) Chart - Part 2', 'timeFrame': 'Baseline, Weeks 12, 24, 36, and 48', 'description': 'LLD was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nThe test was to be performed after BCVA testing, prior to pupil dilation, and distance refraction was to be carried out before Low Luminance Visual Acuity (LLVA) was measured.\n\nLLVA was to be measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the subject read the normally illuminated ETDRS chart. The LLD was calculated as the difference between BCVA and LLVA.\n\nInitially, letters were to be read at a distance of 4 metres from the chart. If \\<20 letters were read at 4 metres, testing at 1 metre should have been performed. LLD was to be reported as number of letters read correctly by the subject.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.'}, {'measure': 'Change From Baseline at Weeks 24, 36, 48, 72 and 96 in Reading Performance, Measured as the Maximum Reading Speed (Words Per Minute), as Assessed by Minnesota Low-vision Reading Test (MNRead) Chart - Part 1', 'timeFrame': 'Baseline, Weeks 24, 36, 48, 72 and 96', 'description': 'The maximum reading speed (MRS) represents the highest reading speed an individual can achieve when print size is not a limiting factor. Essentially, it measures how quickly a person can read text when the print is large enough to be easily readable.\n\nA higher count represents better visual functioning.'}, {'measure': 'Change From Baseline at Weeks 24, 36 and 48 in Reading Performance, Measured as the Maximum Reading Speed (Words Per Minute), as Assessed by Minnesota Low-vision Reading Test (MNRead) Chart - Part 2', 'timeFrame': 'Baseline, Weeks 24, 36 and 48', 'description': 'A higher count represents better visual functioning.\n\nThe untreated control participants were immediately discontinued from the study when the study was early terminated; therefore Week 36 and 48 data in part 2 were not applicable for these the untreated control group.'}, {'measure': 'Change From Baseline at Weeks 24, 36, 48, 72 and 96 in Functional Reading Independence (FRI) Index - Part 1', 'timeFrame': 'Baseline, Weeks 24, 36, 48, 72 and 96', 'description': 'The FRI index is a patient-reported outcome measure developed specifically for use in GA patients. The FRI index evaluates the level of independence subjects have in performing everyday activities that require reading, such as writing a cheque or reading a prescription.\n\nScores derived from the index range from 1 (unable to do) to 4 (total independence).\n\nA higher score represents better visual functioning.'}, {'measure': 'Change From Baseline at Weeks 24, 36 and 48 in Functional Reading Independence (FRI) Index - Part 2', 'timeFrame': 'Baseline, Weeks 24, 36 and 48', 'description': 'The FRI index is a patient-reported outcome measure developed specifically for use in GA patients. The FRI index evaluates the level of independence subjects have in performing everyday activities that require reading, such as writing a cheque or reading a prescription.\n\nScores derived from the index range from 1 (unable to do) to 4 (total independence).\n\nA higher score represents better visual functioning.\n\nThe untreated control participants were immediately discontinued from the study when the study was early terminated; therefore Week 36 and 48 data in part 2 were not applicable for these the untreated control group.'}, {'measure': 'Change From Baseline at Weeks 24, 36, 48, 72 and 96 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Composite Score - Part 1', 'timeFrame': 'Baseline, Weeks 24, 36, 48, 72 and 96', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.'}, {'measure': 'Change From Baseline at Weeks 24, 36 and 48 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Composite Score - Part 2', 'timeFrame': 'Baseline, Weeks 24, 36, and 48', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.\n\nThe untreated control participants were immediately discontinued from the study when the study was early terminated; therefore Week 36 and 48 data in part 2 were not applicable for these the untreated control group.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Geographic atrophy', 'Retinal disease', 'Eye disease', 'Retinal degeneration', 'Macular atrophy', 'Dry age-related macular degeneration'], 'conditions': ['Dry Age-related Macular Degeneration']}, 'referencesModule': {'references': [{'pmid': '37314061', 'type': 'DERIVED', 'citation': 'Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical study was to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to age-related macular degeneration (AMD).', 'detailedDescription': "This was a Phase II, outcomes assessor-masked, multicentre, randomized study to assess the safety and efficacy of two doses of GT005 administered as a single-time subretinal injection in subjects with Geographic Atrophy (GA) secondary to age-related macular degeneration (AMD). Approximately 202 subjects were planned to be randomized to GT005 or the untreated control group.\n\nSubjects entered the study had genotyping and serum complement factor I(CFI) levels assessed. Assessments were either performed at a sponsor-approved laboratory during the EXPLORE screening period or provided through participation in a previous Gyroscope sponsored study. If subjects failed to meet the eligibility criteria for EXPLORE, they were classified as screen failures for this study and could be considered for entry into another Novartis/Gyroscope sponsored study.\n\nAfter providing the informed consent, subjects underwent ophthalmic and clinical assessments to determine eligibility for inclusion in the study.\n\nUpon confirmation of eligibility, subjects in part 1 were randomized to one of two groups: low dose \\[2E10 vg\\], or high dose \\[2E11 vg\\]. Within each group, subjects were allocated to GT005 or untreated control based on a 2:1 ratio. Once part 1 enrolment was completed, and the last active subject completed screening and either was screen-failed or randomized, then Part 2 could commence. In part 2, subjects were randomized to the low dose \\[2E10\\] group or untreated control based on a 2:1 ratio. The study eye was identified for all subjects.\n\nSubjects were stratified by GA lesion size on fundus autofluorescence (FAF) (≤10 mm2 or \\>10 mm2) and presence of choroidal neovascularisation (CNV) in the fellow eye (Yes or No). Randomization of study eyes in the GA lesion size upper stratum of \\>10 mm2 to 17.5 mm2 was capped at 20% of total subjects randomized. Once enrolment capping at 20% based on the upper GA lesion size was reached, eyes that fulfilled the cap criteria were no longer eligible, unless the subject had a CFI rare variant genotype (minor allele frequency ≤1%) previously associated with normal or low serum CFI or had an unreported CFI rare variant genotype. Of all subjects enrolled and randomized in the study, the presence of CNV in the fellow eye was capped at 25% per stratum. A permuted-block randomization method was used to obtain an approximately 2:1 ratio between GT005 and the untreated control groups for each dose group within each stratum.\n\nFollowing randomization, the investigator was informed of the subject's allocated treatment (GT005 or the untreated control group) and the study eye selected. To minimize bias, all imaging endpoint assessments and grading were performed at a Central Reading Centre (CRC), in a masked fashion. For part 1, the Sponsor, subject, investigators, and study personnel performing clinical assessments remained masked to dose received for those allocated to GT005. For part 2, the Sponsor, investigators, subjects, and study personnel performing clinical assessments were unmasked to dose received, since only the low dose was administered.\n\nSubjects randomized to GT005 underwent a single time subretinal administration of the study drug. Vitreous samples were collected during surgery. Following surgery, a prophylactic steroid regimen was prescribed.\n\nThe study consisted of a screening period lasting up to 8 weeks (or up to 12 weeks if agreed by the Sponsor Medical Monitor), followed by a 96-week study period. All subjects were assessed for the occurrence of adverse events (AEs) at each visit and underwent functional visual and retinal imaging,anatomical assessments, and biological sampling as per the schedule of assessments.\n\nThis study was conducted in compliance with Independent ethics committees (IECs) / Institutional review board (IRBs), informed consent regulations, the Declaration of Helsinki, International Council on Harmonisation (ICH) Good Clinical Practices (GCP) Guidelines, and the Food and Drug Administration (FDA) guidance.\n\nOn 24-Aug-2023, the decision was taken to terminate the study and the GT005 program. The decision was aligned with the recommendation of an independent DMC, which concluded that futility criteria had been met for the HORIZON study (GT005-03) and the overall benefit-risk ratio did not support continuation of the current development program as planned. All GT005- treated subjects, who were willing to be transferred into the long-term safety follow-up study were enrolled in the ORACLE (CPPY988A12203B / NCT05481827) study.\n\nIn both Part 1 and Part 2, patients with geographic atrophy secondary to age-related macular degeneration were enrolled. In Part 1, patients with CFI rare variant genotype and low serum CFI level and in Part 2, patients were enrolled regardless of genotypes. Efficacy results were analyzed by arm and also by part. AE and disposition data were reported per arm, but the parts were combined, according to the analysis plan.\n\nPart 1 enrolled subjects with CFI rare variant; Part 2 enrolled subjects regardless of genotype.\n\nThere were no subjects in the high dose arm in Part 2."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able and willing to give written informed consent\n2. Age ≥55 years\n3. Have a clinical diagnosis of GA secondary to AMD in the study eye, as determined by the Investigator, and a diagnosis of AMD in the contralateral eye (except if the subject is monocular)\n4. Have GA lesion(s) total size between or equal to 1.25mm2 to 17.5mm2 in the study eye\n5. The GA lesion(s) in the study eye must reside completely within the FAF image\n6. Up to 25% of the enrolled study population are permitted to have CNV in the fellow eye, defined as either:\n\n 1. Non-exudative/sub-clinical fellow eye CNV identified at Screening, or\n 2. Known history of fellow eye CNV with either ≥2 years since diagnosis or with no active treatment required in 6 months prior to Screening\n7. Have a BCVA of 24 letters (6/95 and 20/320 Snellen acuity equivalent) or better, using ETDRS charts, in the study eye\n8. Part 1 Only: Subjects carrying a CFI rare variant genotype (minor allele frequency of ≤1%) previously associated with low serum CFI or subjects carrying an unreported CFI rare variant genotype that have tested to have a low serum CFI\n9. Able to attend all study visits and complete the study procedures\n10. Women of child-bearing potential must have a negative pregnancy test within 2 weeks prior to randomisation. A pregnancy test is not required for postmenopausal women (defined as being at least 12 consecutive months without menses) or those surgically sterilised (those having a bilateral tubal ligation/bilateral salpingectomy, bilateral tubal occlusive procedure, hysterectomy, or bilateral oophorectomy)\n\nExclusion Criteria:\n\n1. Subjects who have a clinical diagnosis of Stargardt Disease or other retinal dystrophies, confirmed by the central reading centre\n2. Have a history, or evidence, of CNV in the study eye\n3. Presence of moderate/severe or worse non-proliferative diabetic retinopathy in the study eye\n4. Have history of vitrectomy, sub-macular surgery, or macular photocoagulation in the study eye\n5. History of intraocular surgery in the study eye within 12 weeks prior to Screening (Visit 1). Yttrium aluminium garnet capsulotomy is permitted if performed \\>10 weeks prior to Visit 1\n6. Have clinically significant cataract that may require surgery during the study period in the study eye\n7. Presence of moderate to severe glaucomatous optic neuropathy in the study eye; uncontrolled IOP despite the use of two or more topical agents; a history of glaucoma-filtering or valve surgery is also excluded\n8. Axial myopia of greater than -8 dioptres in the study eye\n9. Have any other significant ocular or non-ocular medical or psychiatric condition which, in the opinion of the Investigator, may either put the subject at risk or may influence the results of the study\n10. Have a contraindication to specified protocol corticosteroid regimen\n11. Have received any investigational and/or approved product(s) for the treatment of GA within the past 6 months, or 5 half-lives (whichever is longer) other than nutritional supplements such as the age-related eye disease study (AREDS) formula in the study eye or systemically\n12. Have received a gene or cell therapy at any time\n13. Are unwilling to use two forms of contraception (one of which being a barrier method) for 90 days post-dosing, if relevant\n14. Active malignancy within the past 12 months, except for: appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer with a stable prostate-specific antigen (PSA) ≥12 months'}, 'identificationModule': {'nctId': 'NCT04437368', 'acronym': 'EXPLORE', 'briefTitle': 'EXPLORE: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gyroscope Therapeutics Limited'}, 'officialTitle': 'EXPLORE: A Phase II, Outcomes Assessor-masked, Multicentre, Randomised Study to Evaluate the Safety and Efficacy of Two Doses of GT005 Administered as a Single Subretinal Injection in Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration', 'orgStudyIdInfo': {'id': 'GT005-02'}, 'secondaryIdInfos': [{'id': 'CPPY988A12202', 'type': 'OTHER', 'domain': 'Novartis'}, {'id': '2019-003421-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GT005 Low dose [2E10 vg]', 'description': 'GT005 Low dose \\[2E10 vg\\] (Parts 1 and 2)', 'interventionNames': ['Drug: GT005']}, {'type': 'EXPERIMENTAL', 'label': 'GT005 High dose [2E11 vg]', 'description': 'GT005 High dose \\[2E11 vg\\] (Part 1)', 'interventionNames': ['Drug: GT005']}, {'type': 'NO_INTERVENTION', 'label': 'Untreated control', 'description': 'Untreated control (Parts 1 and 2)'}], 'interventions': [{'name': 'GT005', 'type': 'DRUG', 'description': 'GT005 is a recombinant, non-replicating AAV2 expressing human complement factor I (CFI). GT005 was administered as a single time subretinal injection into the study eye of subjects allocated to one of the two GT005 doses.', 'armGroupLabels': ['GT005 High dose [2E11 vg]', 'GT005 Low dose [2E10 vg]']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85053', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Retinal Research Institute (retina consultants of AZ)', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92647', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Retina Associates of Southern California', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '94303', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Byers Eye Institute at Stanford', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92064', 'city': 'Poway', 'state': 'California', 'country': 'United States', 'facility': 'Retina Consultants San Diego', 'geoPoint': {'lat': 32.96282, 'lon': -117.03586}}, {'zip': '32607', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'VitreoRetinal Associates, P.A.', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Bascom Palmer Eye Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33711', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Retina Vitreous Associates of Florida', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Southeast Retina Center', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60439', 'city': 'Lemont', 'state': 'Illinois', 'country': 'United States', 'facility': 'University Retina Macula Associates PC', 'geoPoint': {'lat': 41.67364, 'lon': -88.00173}}, {'zip': '46290', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Midwest Eye Institute Northside', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '50266', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Wolfe Eye Clinic', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '21209', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Retina Care Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ophthalmic Consultants of Boston (OCB)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55435', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'VitreoRetinal Surgery, PLLC', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Sierra Eye Associates', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '87109', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Vision Research Center Eye Associates of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Retina Associates of Western New York', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati Eye Institute', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Retina', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Casey Eye Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '16507', 'city': 'Erie', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Erie Retinal Surgery, INC', 'geoPoint': {'lat': 42.12922, 'lon': -80.08506}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Mid Atlantic Retina', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37922', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Southeastern Retina Associates, PC', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '38138', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Charles Retina Institute', 'geoPoint': {'lat': 35.14953, 'lon': 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