Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-24 @ 4:27 PM
Study NCT ID:
NCT04435366
Status:
COMPLETED
Last Update Posted:
2025-10-21
First Post:
2020-05-12
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D057092', 'term': 'Geographic Atrophy'}, {'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C005703', 'term': 'salicylhydroxamic acid'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'astellas.resultsdisclosure@astellas.com', 'phone': '800-888-7704', 'title': 'Clinical Transparency', 'organization': 'Astellas Pharma Global Development, Inc'}, 'certainAgreement': {'otherDetails': 'No individual site or investigator may publish or present any results from the trial until a joint, multi-center publication of the trial results is made by Sponsor in conjunction with various participating investigators and appropriate sites contributing data and comments. Subsequently, individual investigators may request to publish or present results from the trial; however approval will be at the sole discretion of the Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality (ACM): From randomization up to 24 months Serious Adverse events (SAEs) and non-SAEs: From first dose up to 24 months', 'description': 'Participants in "ACP only" \\& "ACP and Sham" groups were treated with ACP for up to 2 years, hence safety of ACP is more accurately represented by the randomized ACP group.\n\nACM: All randomized participants. Serious \\& non-SAEs: Those who received at least 1 dose of treatment. Those who received injection of ACP were analyzed in ACP group according to actual injections. One participant randomized to sham didn\'t receive treatment \\& was included in denominator for ACM only and not for other outcomes.', 'eventGroups': [{'id': 'EG000', 'title': 'Avacincaptad Pegol Only (up to 12 Months)', 'description': 'Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1).', 'otherNumAtRisk': 225, 'deathsNumAtRisk': 225, 'otherNumAffected': 100, 'seriousNumAtRisk': 225, 'deathsNumAffected': 4, 'seriousNumAffected': 31}, {'id': 'EG001', 'title': 'Avacincaptad Pegol Only (12 to 24 Months)', 'description': 'Participants were re-randomized at month 12 to receive ACP 2 mg/eye via IVT injections monthly from month 12 through month 23 (Year 2). Participants were followed up until month 24.', 'otherNumAtRisk': 96, 'deathsNumAtRisk': 96, 'otherNumAffected': 51, 'seriousNumAtRisk': 96, 'deathsNumAffected': 1, 'seriousNumAffected': 18}, {'id': 'EG002', 'title': 'Avacincaptad Pegol and Sham Only (12 to 24 Months)', 'description': 'Participants were re-randomized at month 12, to receive ACP 2 mg/eye via IVT injections every other month at months 13, 15, 17, 19, 21, and 23 and sham injections at months 12, 14, 16,18, 20, and 22 (Year 2). Participants were followed up until month 24.', 'otherNumAtRisk': 93, 'deathsNumAtRisk': 93, 'otherNumAffected': 41, 'seriousNumAtRisk': 93, 'deathsNumAffected': 4, 'seriousNumAffected': 16}, {'id': 'EG003', 'title': 'Sham Only (up to 12 Months)', 'description': 'Participants received sham injections through Month 11 (Year 1).', 'otherNumAtRisk': 222, 'deathsNumAtRisk': 222, 'otherNumAffected': 83, 'seriousNumAtRisk': 222, 'deathsNumAffected': 1, 'seriousNumAffected': 36}, {'id': 'EG004', 'title': 'Sham Only (12 to 24 Months)', 'description': 'Participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.', 'otherNumAtRisk': 203, 'deathsNumAtRisk': 203, 'otherNumAffected': 77, 'seriousNumAtRisk': 203, 'deathsNumAffected': 7, 'seriousNumAffected': 25}], 'otherEvents': [{'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Choroidal neovascularisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 21, 'numAffected': 19}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 55, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 22, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 16, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 32, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 34, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 38, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 25, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 32, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 14, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Retinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 27, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 22, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 43, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 18, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}], 'seriousEvents': [{'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Normocytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Coronary artery insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Intracardiac thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Sinus arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Mobile caecum syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, 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{'term': 'Metabolic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Neuromyelitis optica spectrum disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Device lead damage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Neurogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 225, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by Autofluorescence (FAF) at 3 Time Points: Baseline, Month 6, and Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avacincaptad Pegol', 'description': 'Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT injections monthly from month12 through month 23 (Year 2). Participants were followed up until month 24.'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.336', 'spread': '0.032', 'groupId': 'OG000'}, {'value': '0.392', 'spread': '0.033', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0064', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.056', 'ciLowerLimit': '0.016', 'ciUpperLimit': '0.096', 'pValueComment': 'Nominal p-value was used for the comparison between avacincaptad pegol versus sham.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.020', 'groupDescription': 'Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol). Mixed Model for repeated measures (MMRM) was used to compare the treatment groups.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to month 12', 'description': 'GA was associated with age-related macular degeneration (AMD) and caused bilateral, progressive, and irreversible loss of retinal tissue (photoreceptors, retinal pigment epithelium, and choriocapillaris) leading to a permanent loss of visual function and blindness. The least squares mean used to determine mean rate of change in GA growth (slope) was measured by FAF. LS mean \\& SE were based on square-root transformation.', 'unitOfMeasure': 'millimeters (mm)/year', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set'}, {'type': 'PRIMARY', 'title': 'The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by FAF at 5 Timepoints: Baseline, Month 6, Month 12, Month 18, and Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '222', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Avacincaptad Pegol', 'description': 'Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT injections monthly from month12 through month 23 (Year 2). Participants were followed up until month 24.'}, {'id': 'OG001', 'title': 'Avacincaptad Pegol and Sham', 'description': 'Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT every other month (EOM) at months 13, 15, 17, 19, 21, and 23 and sham injections at months 12, 14, 16,18, 20, and 22 (Year 2). Participants were followed up until month 24.'}, {'id': 'OG002', 'title': 'Sham', 'description': 'Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.23', 'spread': '0.124', 'groupId': 'OG000'}, {'value': '2.10', 'spread': '0.126', 'groupId': 'OG001'}, {'value': '2.59', 'spread': '0.085', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0165', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.362', 'ciLowerLimit': '0.066', 'ciUpperLimit': '0.657', 'pValueComment': 'Nominal p-value was used for the comparison between avacincaptad pegol versus sham.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.150', 'groupDescription': 'Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0015', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.488', 'ciLowerLimit': '0.189', 'ciUpperLimit': '0.788', 'pValueComment': 'Nominal p-value was used for the comparison between avacincaptad pegol and sham versus sham.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.152', 'groupDescription': 'Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol and sham).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to month 24', 'description': 'GA was associated with AMD and caused bilateral, progressive, and irreversible loss of retinal tissue (photoreceptors, retinal pigment epithelium, and choriocapillaris) leading to a permanent loss of visual function and blindness. The least square mean rate of GA growth (slope) was measured by FAF. LS mean \\& SE were based on untransformed data.', 'unitOfMeasure': 'mm^2/year', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Re-rand analysis set-The subset of the ITT analysis set who were re-randomized at Month 12 and who were on sham and completed the Month 12 visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Best Corrected Visual Acuity (BCVA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avacincaptad Pegol', 'description': 'Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT injections monthly from month12 through month 23 (Year 2). Participants were followed up until month 24.'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.31', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '-6.48', 'spread': '1.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.58', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.83', 'ciLowerLimit': '-3.79', 'ciUpperLimit': '2.12', 'pValueComment': 'Nominal p-value was used for the comparison between avacincaptad pegol versus sham.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.50', 'groupDescription': 'Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and month 24', 'description': 'BCVA was assessed using ETDRS visual acuity testing charts. The ETDRS Visual Acuity Score (VAS) is defined as the number of letters read on the ETDRS chart. Minimum and maximum possible scores are 0-100. A higher score represented better visual functioning. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Low Luminance (LL) BCVA Using ETDRS Letters at 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avacincaptad Pegol', 'description': 'Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT injections monthly from month12 through month 23 (Year 2). Participants were followed up until month 24.'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). ). Participants were followed up until month 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.58', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '-9.1', 'spread': '1.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.38', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.49', 'ciLowerLimit': '-4.79', 'ciUpperLimit': '1.81', 'pValueComment': 'Nominal p-value was used for the comparison between avacincaptad pegol versus sham.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.68', 'groupDescription': 'Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol).', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and month 24', 'description': 'BCVA was assessed using ETDRS visual acuity testing charts. The ETDRS VAS is defined as the number of letters read on the ETDRS chart. Minimum and maximum possible scores are 0-100. A higher score represented better visual functioning. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. LL BCVA was measured by placing a 2.0 log unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 6, 12 and 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avacincaptad Pegol', 'description': 'Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT injections monthly from month12 through month 23 (Year 2). Participants were followed up until month 24.'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.'}], 'classes': [{'title': 'Change at 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '10.56', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '9.98', 'groupId': 'OG001'}]}]}, {'title': 'Change at 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'spread': '11.05', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '11.01', 'groupId': 'OG001'}]}]}, {'title': 'Change at 18 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.4', 'spread': '12.80', 'groupId': 'OG000'}, {'value': '-4.7', 'spread': '11.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, months 6, 12, and 18', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (VFQ-25) measured the influence of visual disability and visual symptoms on general health domains. The VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. A higher score represented better visual functioning. Each item was then converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively. Each subscale score had a range of 0 to 100 inclusive and were calculated from the re-scaled raw data. A composite score was derived based on the average of the 11 vision-related subscales.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set with available data was analyzed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avacincaptad Pegol', 'description': 'Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT injections monthly from month12 through month 23 (Year 2). Participants were followed up until month 24.'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.735', 'spread': '0.950', 'groupId': 'OG000'}, {'value': '-7.023', 'spread': '0.931', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5929', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.712', 'ciLowerLimit': '-3.326', 'ciUpperLimit': '1.903', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.330', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and month 24', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (VFQ-25) measured the influence of visual disability and visual symptoms on general health domains. The VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. A higher score represented better visual functioning. Each item was then converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively. Each subscale score had a range of 0 to 100 inclusive and were calculated from the re-scaled raw data. A composite score was derived based on the average of the 11 vision-related subscales.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Categorical One-level Loss in VFQ-25 Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avacincaptad Pegol', 'description': 'Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT injections monthly from month12 through month 23 (Year 2). Participants were followed up until month 24.'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.'}], 'classes': [{'title': 'Color Vision', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Distance Vision', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Near Vision', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Peripheral Vision', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'General Vision', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': 'Dependency', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Driving', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'General Health', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'Mental Health', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Ocular Pain', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Role Difficulties', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Social Function', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to month 24', 'description': 'The National Eye Institute VFQ-25 measured the influence of visual disability and visual symptoms on general health domains. The VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. A higher score represented better visual functioning. Each item was then converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively.Categorical one-level loss in each item was defined as decline of one or more levels at Month 24 on the original scale from Baseline (equivalently 20 points for general vision and 25 points for other vision items in a 0 to 100 scale).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set with available data was analyzed'}, {'type': 'SECONDARY', 'title': 'Time to Persistent Vision Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avacincaptad Pegol', 'description': 'Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT injections monthly from month12 through month 23 (Year 2). Participants were followed up until month 24.'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.02', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '23.0'}, {'value': '13.93', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '23.2'}]}]}], 'analyses': [{'pValue': '0.6424', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.57', 'ciUpperLimit': '1.42', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to month 24', 'description': 'Vision loss event was defined as a loss of ≥ 15 letters (equivalent to a loss of 3 lines on the ETDRS chart) in BCVA from Baseline measured at any two or more consecutive visits up to Month 24. These parameters were chosen as a 3-line BCVA loss (equivalent to doubling of visual angle) is widely recognized as a significant deterioration in vision and a minimum of two consecutive visits was representative of persistent disease progression. BCVA was assessed using ETDRS visual acuity testing charts. The ETDRS VAS was defined as the number of letters read on the ETDRS chart. Min and max possible scores are 0-100. A higher score represents better visual functioning. Kaplan-Meier method was used for analysis. Participants with an event were reported and not the median time to event.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Avacincaptad Pegol', 'description': 'Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT injections monthly from month12 through month 23 (Year 2). Participants were followed up until month 24.'}, {'id': 'FG001', 'title': 'Avacincaptad Pegol and Sham', 'description': 'Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT every other month (EOM) at months 13, 15, 17, 19, 21, and 23 and sham injections at months 12, 14, 16,18, 20, and 22 (Year 2). Participants were followed up until month 24.'}, {'id': 'FG002', 'title': 'Sham', 'description': 'Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.'}], 'periods': [{'title': 'Year 1 (12 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '225'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '223'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '225'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '222'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '205'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Patient non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Year 2 (12 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}, {'groupId': 'FG001', 'numSubjects': '93'}, {'groupId': 'FG002', 'numSubjects': '203'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '83'}, {'groupId': 'FG002', 'numSubjects': '184'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Participants ≥ 50 years of age diagnosed with geographic atrophy (GA) that was at least partly within 1.5 mm radius from the foveal center were enrolled in the study.', 'preAssignmentDetails': 'Participants who met all inclusion criteria and none of the exclusion criteria were enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'BG000'}, {'value': '222', 'groupId': 'BG001'}, {'value': '447', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Avacincaptad Pegol', 'description': 'Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT injections monthly or ACP 2 mg/eye via IVT injections EOM at months 13, 15, 17, 19, 21, and 23 and sham injections at months 12, 14, 16,18, 20, and 22 (Year 2). Participants were followed up until month 24.'}, {'id': 'BG001', 'title': 'Sham', 'description': 'Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '76.3', 'spread': '8.6', 'groupId': 'BG000'}, {'value': '76.7', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '76.5', 'spread': '8.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '310', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '346', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], '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': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '368', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) analysis set consisted of all randomized participants who received at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-24', 'size': 5497428, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-10-27T14:49', 'hasProtocol': True}, {'date': '2022-04-07', 'size': 2316910, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-07-26T02:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participant, "Evaluating" Investigator, Reading Center Personnel, and Sponsor Personnel are masked'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 448}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-10', 'dispFirstSubmitDate': '2023-07-21', 'completionDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-16', 'studyFirstSubmitDate': '2020-05-12', 'resultsFirstSubmitDate': '2023-11-01', 'studyFirstSubmitQcDate': '2020-06-15', 'dispFirstPostDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2023-12-07', 'studyFirstPostDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by Autofluorescence (FAF) at 3 Time Points: Baseline, Month 6, and Month 12', 'timeFrame': 'Baseline to month 12', 'description': 'GA was associated with age-related macular degeneration (AMD) and caused bilateral, progressive, and irreversible loss of retinal tissue (photoreceptors, retinal pigment epithelium, and choriocapillaris) leading to a permanent loss of visual function and blindness. The least squares mean used to determine mean rate of change in GA growth (slope) was measured by FAF. LS mean \\& SE were based on square-root transformation.'}, {'measure': 'The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by FAF at 5 Timepoints: Baseline, Month 6, Month 12, Month 18, and Month 24', 'timeFrame': 'Baseline to month 24', 'description': 'GA was associated with AMD and caused bilateral, progressive, and irreversible loss of retinal tissue (photoreceptors, retinal pigment epithelium, and choriocapillaris) leading to a permanent loss of visual function and blindness. The least square mean rate of GA growth (slope) was measured by FAF. LS mean \\& SE were based on untransformed data.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Best Corrected Visual Acuity (BCVA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at 24 Months', 'timeFrame': 'Baseline and month 24', 'description': 'BCVA was assessed using ETDRS visual acuity testing charts. The ETDRS Visual Acuity Score (VAS) is defined as the number of letters read on the ETDRS chart. Minimum and maximum possible scores are 0-100. A higher score represented better visual functioning. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.'}, {'measure': 'Change From Baseline in Low Luminance (LL) BCVA Using ETDRS Letters at 24 Months', 'timeFrame': 'Baseline and month 24', 'description': 'BCVA was assessed using ETDRS visual acuity testing charts. The ETDRS VAS is defined as the number of letters read on the ETDRS chart. Minimum and maximum possible scores are 0-100. A higher score represented better visual functioning. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. LL BCVA was measured by placing a 2.0 log unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart.'}, {'measure': 'Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 6, 12 and 18 Months', 'timeFrame': 'Baseline, months 6, 12, and 18', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (VFQ-25) measured the influence of visual disability and visual symptoms on general health domains. The VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. A higher score represented better visual functioning. Each item was then converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively. Each subscale score had a range of 0 to 100 inclusive and were calculated from the re-scaled raw data. A composite score was derived based on the average of the 11 vision-related subscales.'}, {'measure': 'Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 24 Months', 'timeFrame': 'Baseline and month 24', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (VFQ-25) measured the influence of visual disability and visual symptoms on general health domains. The VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. A higher score represented better visual functioning. Each item was then converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively. Each subscale score had a range of 0 to 100 inclusive and were calculated from the re-scaled raw data. A composite score was derived based on the average of the 11 vision-related subscales.'}, {'measure': 'Number of Participants With Categorical One-level Loss in VFQ-25 Subscale', 'timeFrame': 'Baseline up to month 24', 'description': 'The National Eye Institute VFQ-25 measured the influence of visual disability and visual symptoms on general health domains. The VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. A higher score represented better visual functioning. Each item was then converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively.Categorical one-level loss in each item was defined as decline of one or more levels at Month 24 on the original scale from Baseline (equivalently 20 points for general vision and 25 points for other vision items in a 0 to 100 scale).'}, {'measure': 'Time to Persistent Vision Loss', 'timeFrame': 'Baseline up to month 24', 'description': 'Vision loss event was defined as a loss of ≥ 15 letters (equivalent to a loss of 3 lines on the ETDRS chart) in BCVA from Baseline measured at any two or more consecutive visits up to Month 24. These parameters were chosen as a 3-line BCVA loss (equivalent to doubling of visual angle) is widely recognized as a significant deterioration in vision and a minimum of two consecutive visits was representative of persistent disease progression. BCVA was assessed using ETDRS visual acuity testing charts. The ETDRS VAS was defined as the number of letters read on the ETDRS chart. Min and max possible scores are 0-100. A higher score represents better visual functioning. Kaplan-Meier method was used for analysis. Participants with an event were reported and not the median time to event.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Geographic Atrophy (GA)', 'Age-related Macular Degeneration', 'AMD', 'Complement C5 inhibitor', 'avacincaptad pegol', 'IZERVAY'], 'conditions': ['Geographic Atrophy', 'Macular Degeneration']}, 'referencesModule': {'references': [{'pmid': '41407269', 'type': 'DERIVED', 'citation': 'Khanani AM, Danzig CJ, Heier JS, Jaffe GJ, Kaiser PK, Lally DR, Patel SS, Vajzovic L, Weng CY, Patel H, Clark J, Desai D, Luo D, Henry E, Holz FG; GATHER2 trial investigators. Avacincaptad pegol for geographic atrophy secondary to age-related macular degeneration: 2-year efficacy and safety results from the GATHER2 phase 3 trial. Ophthalmology. 2025 Dec 15:S0161-6420(25)00790-0. doi: 10.1016/j.ophtha.2025.12.011. Online ahead of print.'}, {'pmid': '37696275', 'type': 'DERIVED', 'citation': 'Khanani AM, Patel SS, Staurenghi G, Tadayoni R, Danzig CJ, Eichenbaum DA, Hsu J, Wykoff CC, Heier JS, Lally DR, Mones J, Nielsen JS, Sheth VS, Kaiser PK, Clark J, Zhu L, Patel H, Tang J, Desai D, Jaffe GJ; GATHER2 trial investigators. Efficacy and safety of avacincaptad pegol in patients with geographic atrophy (GATHER2): 12-month results from a randomised, double-masked, phase 3 trial. Lancet. 2023 Oct 21;402(10411):1449-1458. doi: 10.1016/S0140-6736(23)01583-0. Epub 2023 Sep 8.'}, {'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.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicaltrials.astellas.com/study/ISEE2008/', 'label': 'Link to results and other applicable study documents on the Astellas Clinical Trials website.'}, {'url': 'https://www.trialsummaries.com/Study/StudyDetails?id=26044&tenant=MT_AST_9011', 'label': 'Link to plain language summary of the study on the Trial Results Summaries website.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study was to evaluate the safety and efficacy of avacincaptad pegol intravitreal administration in participants with geographic atrophy secondary to age-related macular degeneration (AMD)', 'detailedDescription': 'Participants were randomized in a 1:1 ratio to the following monthly treatment groups:\n\n* Avacincaptad pegol 2 mg\n* Sham\n\nAt Month 12, the participants in the avacincaptad pegol 2mg treatment group were re-randomized to receive the study drug either on a monthly basis or on an every other month basis\n\nThe participants initially randomized to sham treatment continued with monthly sham administration through Month 23\n\nAll participants had a final follow up visit at Month 24'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects of either gender aged ≥ 50 years\n* Diagnosis of Non-foveal GA secondary to dry AMD\n\nExclusion Criteria:\n\n* Any prior treatment for AMD (dry or wet) or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals\n* Any intraocular surgery or thermal laser within 3 months of trial entry.\n* Any prior thermal laser in the macular region, regardless of indication\n* Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 12 weeks.\n* Previous therapeutic radiation in the region of the study eye\n* Any sign of diabetic retinopathy in either eye'}, 'identificationModule': {'nctId': 'NCT04435366', 'briefTitle': 'A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase 3 Multicenter, Randomized, Double Masked, Sham- Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura (Complement C5 Inhibitor) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration', 'orgStudyIdInfo': {'id': 'ISEE2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Avacincaptad Pegol', 'description': 'Participants received avacincaptad pegol (ACP) 2 milligram (mg)/eye via intravitreal (IVT) injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT injections monthly from month12 through month 23 (Year 2).', 'interventionNames': ['Drug: Avacincaptad Pegol']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': 'Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham administration from month 12 through month 23 (Year 2).', 'interventionNames': ['Drug: Sham']}, {'type': 'EXPERIMENTAL', 'label': 'Avacincaptad pegol and Sham', 'description': 'Participants who received ACP 2mg monthly through Month 11 (Year 1) were re-randomized at month 12, to receive ACP 2 mg/eye via IVT injections every other month at months 13, 15, 17, 19, 21, and 23 and sham injections at months 12, 14, 16,18, 20, and 22.', 'interventionNames': ['Drug: Avacincaptad Pegol']}], 'interventions': [{'name': 'Avacincaptad Pegol', 'type': 'DRUG', 'otherNames': ['Zimura (previous name)', 'IZERVAY'], 'description': 'Avacincaptad Pegol Intravitreal Injection', 'armGroupLabels': ['Avacincaptad Pegol', 'Avacincaptad pegol and Sham']}, {'name': 'Sham', 'type': 'DRUG', 'description': 'Sham Administration (includes placement of the blunt opening of an empty, needleless syringe barrel on the conjunctiva in the inferotemporal quadrant of 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