Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2026-01-04 @ 8:31 AM
Study NCT ID:
NCT02288559
Status:
COMPLETED
Last Update Posted:
2019-09-25
First Post:
2014-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Participants With Geographic Atrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057092', 'term': 'Geographic Atrophy'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C005703', 'term': 'salicylhydroxamic acid'}, {'id': 'C000603963', 'term': 'lampalizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'global.trial_information@roche.com', 'phone': '(+41) 616878333', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to approximately 30 weeks', 'description': 'Safety analysis population included all randomized participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Lampalizumab Q2W', 'description': 'Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 21, 'seriousNumAtRisk': 46, 'deathsNumAffected': 2, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Lampalizumab Q4W', 'description': 'Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 13, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Sham Q2W', 'description': 'Participants received sham comparator Q2W (once every 2 weeks) for 24 weeks.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 7, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Sham Q4W', 'description': 'Participants received sham comparator Q4W (once every 4 weeks) for 24 weeks.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 7, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Deafness unilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Middle ear effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Vitreous detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Cataract subcapsular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Photopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Posterior capsule opacification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Retinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Borderline glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Cataract nuclear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Conjunctival oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Eyelid ptosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Neovascular age-related macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Tooth fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Neutrophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Prothrombin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Device breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Upper respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}], 'seriousEvents': [{'term': 'Scleritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Postural orthostatic tachycardia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Malignant melanoma in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Non-hodgkins lymphoma recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Embolic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluorescence (FAF) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Q2W', 'description': 'Participants received sham comparator Q2W (once every 2 weeks) for 24 weeks.'}, {'id': 'OG001', 'title': 'Sham Q4W', 'description': 'Participants received sham comparator Q4W (once every 4 weeks) for 24 weeks.'}, {'id': 'OG002', 'title': 'Lampalizumab Q2W', 'description': 'Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks.'}, {'id': 'OG003', 'title': 'Lampalizumab Q4W', 'description': 'Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.614', 'spread': '0.188', 'groupId': 'OG000'}, {'value': '1.121', 'spread': '0.179', 'groupId': 'OG001'}, {'value': '1.049', 'spread': '0.094', 'groupId': 'OG002'}, {'value': '0.911', 'spread': '0.123', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0428', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Adjusted Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.435', 'ciLowerLimit': '0.162', 'ciUpperLimit': '0.707', 'statisticalMethod': 'Mixed-Effect Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM analysis variables: treatment group, visit, treatment-by-visit interaction, baseline GA area, and BCVA ETDRS chart Snellen equivalent category.'}, {'pValue': '0.3361', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in Adjusted Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.210', 'ciLowerLimit': '-0.491', 'ciUpperLimit': '0.071', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM analysis variables: treatment group, visit, treatment-by-visit interaction, baseline GA area, and BCVA ETDRS chart Snellen equivalent category.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'GA or the death of photoreceptors and surrounding cells in the retina, is a common condition in participants with age-related macular degeneration (AMD). The death of these photoreceptors results in lesions that cause vision loss. The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). BCVA=best corrected visual acuity; ETDRS=Early Treatment Diabetic Retinopathy Scale.', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population included participants who were randomly assigned to study treatment and had at least one post-baseline GA area measurement. Number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Serum Concentrations of Lampalizumab (Q2W)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lampalizumab Q2W', 'description': 'Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks.'}], 'classes': [{'title': 'Day 1 (Predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and geometric coefficient of variation were not calculable as more than one-third of the values were LTR.', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 (Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.31', 'spread': 'NA', 'comment': 'Geometric coefficient of variation was not calculable as more than one-third of the values were LTR.', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.5', 'spread': '89.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63.6', 'spread': '69.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64.4', 'spread': '83.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.2', 'spread': '68.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '62.7', 'spread': '141.4', 'groupId': 'OG000'}]}]}, {'title': 'Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.92', 'spread': '1070.9', 'groupId': 'OG000'}]}]}, {'title': 'Unscheduled predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.500', 'spread': 'NA', 'comment': 'Geometric coefficient of variation was not calculable as more than one-third of the values were LTR.', 'groupId': 'OG000'}]}]}, {'title': 'Unscheduled postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.500', 'spread': 'NA', 'comment': 'Geometric coefficient of variation was not calculable as more than one-third of the values were LTR.', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (Day 1, predose and postdose), Weeks 2,4,8,16 and 24, early termination, unscheduled predose and postdose', 'description': 'Lower than reportable (LTR) results on pre-dose sample were set to 0, and LTR results on post-dose sample were set to half of lower limit of quantification (LLOQ) (0.5 nanograms per milliliter (ng/mL)).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics (PK) population included participants randomized to lampalizumab treatment who received at least one dose of study drug and provided at least one serum sample for determination of lampalizumab. Number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Serum Concentrations of Lampalizumab (Q4W)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lampalizumab Q4W', 'description': 'Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks.'}], 'classes': [{'title': 'Day 1 (Predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and geometric coefficient of variation were not calculable as more than one-third of the values were LTR.', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 (Postdose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.08', 'spread': 'NA', 'comment': 'Geometric coefficient of variation was not calculable as more than one-third of the values were LTR.', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.52', 'spread': '114.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.3', 'spread': '84.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.66', 'spread': '88.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.92', 'spread': '102.0', 'groupId': 'OG000'}]}]}, {'title': 'Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.1', 'spread': 'NA', 'comment': 'Geometric coefficient of variation was not calculable as more than one-third of the values were LTR.', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (Day 1, predose and postdose), Weeks 4,8,16 and 24, early termination', 'description': 'LTR results on pre-dose sample were set to 0, and LTR results on post-dose sample were set to half of LLOQ (0.5 ng/mL).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included participants randomized to lampalizumab treatment who received at least one dose of study drug and provided at least one serum sample for determination of lampalizumab. Number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Ocular Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Q2W', 'description': 'Participants received sham comparator Q2W (once every 2 weeks) for 24 weeks.'}, {'id': 'OG001', 'title': 'Sham Q4W', 'description': 'Participants received sham comparator Q4W (once every 4 weeks) for 24 weeks.'}, {'id': 'OG002', 'title': 'Lampalizumab Q2W', 'description': 'Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks.'}, {'id': 'OG003', 'title': 'Lampalizumab Q4W', 'description': 'Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}, {'value': '9.1', 'groupId': 'OG001'}, {'value': '63.0', 'groupId': 'OG002'}, {'value': '63.6', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to approximately 30 weeks', 'description': 'An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all randomized participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Systemic (Non-ocular) Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Q2W', 'description': 'Participants received sham comparator Q2W (once every 2 weeks) for 24 weeks.'}, {'id': 'OG001', 'title': 'Sham Q4W', 'description': 'Participants received sham comparator Q4W (once every 4 weeks) for 24 weeks.'}, {'id': 'OG002', 'title': 'Lampalizumab Q2W', 'description': 'Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks.'}, {'id': 'OG003', 'title': 'Lampalizumab Q4W', 'description': 'Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}, {'value': '63.6', 'groupId': 'OG001'}, {'value': '52.2', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to approximately 30 weeks', 'description': 'An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Non-ocular AEs were the systemic events.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all randomized participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Anti-Lampalizumab Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Q2W', 'description': 'Participants received sham comparator Q2W (once every 2 weeks) for 24 weeks.'}, {'id': 'OG001', 'title': 'Sham Q4W', 'description': 'Participants received sham comparator Q4W (once every 4 weeks) for 24 weeks.'}, {'id': 'OG002', 'title': 'Lampalizumab Q2W', 'description': 'Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks.'}, {'id': 'OG003', 'title': 'Lampalizumab Q4W', 'description': 'Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks.'}], 'classes': [{'title': 'Treatment-induced ADA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Treatment-enhanced ADA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to approximately 30 weeks', 'description': 'Having treatment-induced anti-drug antibodies (ADAs) was defined as being ADA-negative at baseline and ADA-positive at any post-baseline timepoint. Having treatment-enhanced ADAs was defined as being ADA-positive at baseline with titer values increased by 0.6 titer units at any post-baseline timepoint.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all randomized participants who received at least one dose of study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sham Q2W', 'description': 'Participants received sham comparator Q2W (once every 2 weeks) for 24 weeks.'}, {'id': 'FG001', 'title': 'Sham Q4W', 'description': 'Participants received sham comparator Q4W (once every 4 weeks) for 24 weeks.'}, {'id': 'FG002', 'title': 'Lampalizumab Q2W', 'description': 'Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks.'}, {'id': 'FG003', 'title': 'Lampalizumab Q4W', 'description': 'Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '46'}, {'groupId': 'FG003', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 332 participants were screened and 92 participants were randomized out of which 3 participants from one site were removed from the randomized population due to serious good clinical practice (GCP) noncompliance. Out of 89, 4 participants were excluded from the randomized population as they did not have any post-baseline measurement.\n\n.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '85', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Sham Q2W', 'description': 'Participants received sham comparator Q2W (once every 2 weeks) for 24 weeks.'}, {'id': 'BG001', 'title': 'Sham Q4W', 'description': 'Participants received sham comparator Q4W (once every 4 weeks) for 24 weeks.'}, {'id': 'BG002', 'title': 'Lampalizumab Q2W', 'description': 'Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks.'}, {'id': 'BG003', 'title': 'Lampalizumab Q4W', 'description': 'Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.4', 'spread': '4.4', 'groupId': 'BG000'}, {'value': '78.2', 'spread': '7.7', 'groupId': 'BG001'}, {'value': '78.3', 'spread': '8.0', 'groupId': 'BG002'}, {'value': '80.1', 'spread': '7.7', 'groupId': 'BG003'}, {'value': '78.2', 'spread': '7.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '82', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Geographic Atrophy Area, as Assessed by Fundus Autofluorescence (FAF)', 'classes': [{'categories': [{'measurements': [{'value': '7.034', 'spread': '2.747', 'groupId': 'BG000'}, {'value': '6.891', 'spread': '3.050', 'groupId': 'BG001'}, {'value': '8.755', 'spread': '4.059', 'groupId': 'BG002'}, {'value': '7.172', 'spread': '4.192', 'groupId': 'BG003'}, {'value': '7.923', 'spread': '3.894', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'GA or the death of photoreceptors and surrounding cells in the retina, is a common condition in participants with age-related macular degeneration (AMD). The death of these photoreceptors results in lesions that cause vision loss. The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center.', 'unitOfMeasure': 'millimeter square (mm^2)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Modified intent-to-treat (mITT) population included participants who were randomly assigned to study treatment and had at least one post-baseline geographic atrophy (GA) area measurement.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-12-24', 'size': 17598495, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-01-24T08:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'dispFirstSubmitDate': '2018-06-01', 'completionDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-23', 'studyFirstSubmitDate': '2014-11-07', 'dispFirstSubmitQcDate': '2018-06-01', 'resultsFirstSubmitDate': '2019-01-24', 'studyFirstSubmitQcDate': '2014-11-10', 'dispFirstPostDateStruct': {'date': '2018-06-07', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-24', 'studyFirstPostDateStruct': {'date': '2014-11-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluorescence (FAF) at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'GA or the death of photoreceptors and surrounding cells in the retina, is a common condition in participants with age-related macular degeneration (AMD). The death of these photoreceptors results in lesions that cause vision loss. The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). BCVA=best corrected visual acuity; ETDRS=Early Treatment Diabetic Retinopathy Scale.'}], 'secondaryOutcomes': [{'measure': 'Serum Concentrations of Lampalizumab (Q2W)', 'timeFrame': 'Baseline (Day 1, predose and postdose), Weeks 2,4,8,16 and 24, early termination, unscheduled predose and postdose', 'description': 'Lower than reportable (LTR) results on pre-dose sample were set to 0, and LTR results on post-dose sample were set to half of lower limit of quantification (LLOQ) (0.5 nanograms per milliliter (ng/mL)).'}, {'measure': 'Serum Concentrations of Lampalizumab (Q4W)', 'timeFrame': 'Baseline (Day 1, predose and postdose), Weeks 4,8,16 and 24, early termination', 'description': 'LTR results on pre-dose sample were set to 0, and LTR results on post-dose sample were set to half of LLOQ (0.5 ng/mL).'}, {'measure': 'Percentage of Participants With Ocular Adverse Events (AEs)', 'timeFrame': 'Baseline up to approximately 30 weeks', 'description': 'An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.'}, {'measure': 'Percentage of Participants With Systemic (Non-ocular) Adverse Events', 'timeFrame': 'Baseline up to approximately 30 weeks', 'description': 'An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Non-ocular AEs were the systemic events.'}, {'measure': 'Percentage of Participants With Anti-Lampalizumab Antibodies', 'timeFrame': 'Baseline up to approximately 30 weeks', 'description': 'Having treatment-induced anti-drug antibodies (ADAs) was defined as being ADA-negative at baseline and ADA-positive at any post-baseline timepoint. Having treatment-enhanced ADAs was defined as being ADA-positive at baseline with titer values increased by 0.6 titer units at any post-baseline timepoint.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Geographic Atrophy']}, 'descriptionModule': {'briefSummary': 'This multicenter, randomized, single-masked, sham injection-controlled study will investigate the exposure-response and safety of lampalizumab administered intravitreally every 2 weeks (Q2W) or every 4 weeks (Q4W) for 24 weeks in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). A safety run-in assessment will be conducted prior to initiating enrollment in the randomized study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Complement Factor I (CFI) profile biomarker-positive result\n* Women of child bearing potential and men should remain abstinent or use contraceptive methods\n\nExclusion Criteria:\n\n* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in study eye\n* Previous subfoveal focal laser photocoagulation in study eye\n* Laser photocoagulation in the study eye\n* Prior treatment with external-beam radiation therapy or transpupillary thermotherapy in study eye\n* Previous intravitreal drug administration in study eye. A single intraoperative administration of a corticosteroid during cataract surgery at least 3 months prior to screening is permitted\n* Previous cell-based intraocular treatment in study eye\n* Intraocular surgery in study eye\n* Uncontrolled glaucoma and history of glaucoma-filtering surgery in study eye\n* History of corneal transplant in study eye\n* GA in either eye due to causes other than AMD\n* Proliferative diabetic retinopathy in either eye\n* Active or history of neovascular (wet) AMD in either eye\n* History of idiopathic or autoimmune-associated uveitis, ocular or intraocular conditions, and infectious or inflammatory ocular disease\n* Active uveitis and infectious conjunctivitis, keratitis, scleritis or endophthalmitis\n* Previous systemic treatment with complement inhibitor and with inhibitors/modulators of visual cycle\n* Previous expression vector mediated intraocular treatments\n* Uncontrolled blood pressure and atrial fibrillation\n* Medical conditions associated with clinically significant risk for bleeding-\n* Predisposition or history of increased risk for infection\n* Active malignancy within the previous 12 months except for appropriately treated carcinoma in situ of cervix, resolved non-melanoma skin carcinoma, and prostate cancer with a Gleason score of less than or equal to 6, and a stable prostate-specific antigen for greater than or equal to (\\>/=) 12 months\n* History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of lampalizumab injection\n* Women of child bearing potential must have a negative serum pregnancy test within 28 days prior to initiation of study treatment\n* Previous participation in other studies of investigational drugs'}, 'identificationModule': {'nctId': 'NCT02288559', 'briefTitle': 'A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Participants With Geographic Atrophy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase II, Multicenter, Randomized, Single-Masked, Sham Injection-Controlled Exposure-Response Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Patients With Geographic Atrophy', 'orgStudyIdInfo': {'id': 'GX29455'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lampalizumab: Open-label Safety Run-In', 'description': 'Participants will receive 10 milligrams (mg) lampalizumab intravitreally Q2W during the safety run-in period.', 'interventionNames': ['Drug: Lampalizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Q2W Lampalizumab: Randomized Treatment', 'description': 'Participants will receive 10 mg dose of lampalizumab intravitreally Q2W during the 24-week treatment period.', 'interventionNames': ['Drug: Lampalizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Q4W Lampalizumab: Randomized Treatment', 'description': 'Participants will receive 10 mg dose of lampalizumab intravitreally Q4W during the 24-week treatment period.', 'interventionNames': ['Drug: Lampalizumab']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham: Randomized Treatment', 'description': 'Participants randomized to control arms will receive sham injections, that mimics intravitreal injection of lampalizumab.', 'interventionNames': ['Other: Sham']}], 'interventions': [{'name': 'Sham', 'type': 'OTHER', 'description': 'Sham injection will be administered as a matching intravitreal injection of lampalizumab.', 'armGroupLabels': ['Sham: Randomized Treatment']}, {'name': 'Lampalizumab', 'type': 'DRUG', 'description': '10 mg dose of lampalizumab administered intravitreally', 'armGroupLabels': ['Lampalizumab: Open-label Safety Run-In', 'Q2W Lampalizumab: Randomized Treatment', 'Q4W Lampalizumab: Randomized Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Barnet Dulaney Perkins Eye Center', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85711', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona; Banner University Medical, Department of Opthalmology', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72764', 'city': 'Springdale', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Northwest Arkansas Retina Associates', 'geoPoint': {'lat': 36.18674, 'lon': -94.12881}}, {'zip': '95008', 'city': 'Campbell', 'state': 'California', 'country': 'United States', 'facility': 'Retinal Diagnostic Center', 'geoPoint': {'lat': 37.28717, 'lon': -121.94996}}, {'zip': '91436', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'The Retina Partners', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Retina Associates', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '94109', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'West Coast Retina Medical Group', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '93103', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'California Retina Consultants', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '80401', 'city': 'Golden', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Retina Associates, PC', 'geoPoint': {'lat': 39.75554, 'lon': -105.2211}}, {'zip': '33426', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Eye Microsurgical Inst', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33912', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'National Ophthalmic Research Institute', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32901', 'city': 'Melbourne', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Eye Associates', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'zip': '33410', 'city': 'Palm Beach Gardens', 'state': 'Florida', 'country': 'United States', 'facility': 'Retina Care Specialists', 'geoPoint': {'lat': 26.82339, 'lon': -80.13865}}, {'zip': '32503', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Retina Specialty Institute', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '50266', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Wolfe Eye Clinic', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '21237', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Elman Retina Group', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Vitreoretinal Surgery', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '63128', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'The Retina Institute', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Sierra Eye Associates', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Eye Associates of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '28803', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Western Carolina Retinal Associate PA', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '28210', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Char Eye Ear &Throat Assoc', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati Eye Institute', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44122', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Retina Assoc of Cleveland Inc', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73099', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Dean McGee Eye Institute', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '29414', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Retina Cons of Charleston', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29223', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Retina Center PA', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Charles Retina Institution', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '37923', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Southeastern Retina Associates', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Retina PC.', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '79606', 'city': 'Abilene', 'state': 'Texas', 'country': 'United States', 'facility': 'W Texas Retina Consultants PA', 'geoPoint': {'lat': 32.44874, 'lon': -99.73314}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Retina Associates', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75115', 'city': 'DeSoto', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Specialists', 'geoPoint': {'lat': 32.58986, 'lon': -96.85695}}, {'zip': '23451', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Wagner Macula & Retina Center', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}