Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-02-20 @ 6:46 PM
Study NCT ID:
NCT02686658
Status:
COMPLETED
Last Update Posted:
2025-06-10
First Post:
2016-02-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Zimura in Participants With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@ivericbio.com', 'phone': '609-474-6755', 'title': 'Medical Director', 'organization': 'IVERIC Bio, 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': 'Adverse events were recorded starting at Day 1 after the first dose of study drug and continuing until 30 days after the last dose or until the last follow-up visit required by the protocol, whichever comes later (up to approximately 18 months from first dose).', 'description': 'The analysis population for all-cause mortality, serious adverse events (SAEs), and non-serious adverse events (NSAEs) consisted of all participants who received at least one dose of study treatment. Participants who received an injection of Zimura during this study were analyzed in the appropriate Zimura group according to the actual injections received.', 'eventGroups': [{'id': 'EG000', 'title': 'Zimura 1 mg [Part 1]', 'description': 'Participants received 1 mg of Zimura in the study eye administered via intravitreal (IVT) injection on Day 1 and monthly up to 18 months.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 13, 'seriousNumAtRisk': 26, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Zimura 2 mg [Part 1]', 'description': 'Participants received 2 mg of Zimura in the study eye administered via IVT injection on Day 1 and monthly up to 18 months.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 13, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Sham [Part 1]', 'description': 'Participants received a Sham injection of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 10, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'Zimura 2 mg (Zimura 2mg+Sham) [Part 2]', 'description': 'Participants received 2 mg of Zimura in the study eye administered via IVT injection and a Sham administration on Day 1 and monthly up to 18 months.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 34, 'seriousNumAtRisk': 42, 'deathsNumAffected': 1, 'seriousNumAffected': 8}, {'id': 'EG004', 'title': 'Zimura 4 mg (Zimura 2mg+Zimura 2mg) [Part 2]', 'description': 'Participants received 4 mg of Zimura in the study eye administered via 2 IVT injections on Day 1 and monthly up to 18 months.', 'otherNumAtRisk': 83, 'deathsNumAtRisk': 83, 'otherNumAffected': 66, 'seriousNumAtRisk': 83, 'deathsNumAffected': 1, 'seriousNumAffected': 21}, {'id': 'EG005', 'title': 'Sham (Sham+Sham) [Part 2]', 'description': 'Participants received 2 Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.', 'otherNumAtRisk': 84, 'deathsNumAtRisk': 84, 'otherNumAffected': 49, 'seriousNumAtRisk': 84, 'deathsNumAffected': 1, 'seriousNumAffected': 21}, {'id': 'EG006', 'title': 'Zimura (Any Dose) [Part 1 & Part 2 Combined]', 'description': 'Participants received a 1 mg, 2 mg, or 4 mg dose of Zimura in the study eye administered via 1 or 2 IVT injection(s) (or via IVT injection and a Sham administration) on Day 1 and monthly up to 18 months.', 'otherNumAtRisk': 176, 'deathsNumAtRisk': 176, 'otherNumAffected': 126, 'seriousNumAtRisk': 176, 'deathsNumAffected': 3, 'seriousNumAffected': 36}, {'id': 'EG007', 'title': 'Sham [Part 1 & Part 2 Combined]', 'description': 'Participants received a Sham injection (or 2 Sham injections) of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.', 'otherNumAtRisk': 110, 'deathsNumAtRisk': 110, 'otherNumAffected': 59, 'seriousNumAtRisk': 110, 'deathsNumAffected': 1, 'seriousNumAffected': 28}], 'otherEvents': [{'term': 'Conjunctival haemorrhage *', 'notes': '\\* included study and fellow eye events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 28}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 41}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 13}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Neovascular age-related macular degeneration*', 'notes': '\\* included study and fellow eye events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 23}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Conjunctival hyperaemia*', 'notes': '\\* included study and fellow eye events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 12}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Punctate keratitis*', 'notes': '\\* included study and fellow eye events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 10}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Eye pain*', 'notes': '\\* included study and fellow eye events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 10}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vitreous detachment*', 'notes': '\\* included study and fellow eye events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 9}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cataract*', 'notes': '\\* included study and fellow eye events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Visual acuity reduced*', 'notes': '\\* included study and fellow eye events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 7}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Conjunctival oedema*', 'notes': '\\* included study and fellow eye events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 7}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Choroidal neovascularization*', 'notes': '\\* included study and fellow eye events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Eye irritation*', 'notes': '\\* included study and fellow eye events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Posterior capsule opacification*', 'notes': '\\* included study and fellow eye events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 19}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 11}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 19}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 26}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 14}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, 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'MedDRA 18.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Subclavian artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '84', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Zimura 2 mg [Part 1 & Part 2 Combined]', 'description': 'Participants received 2 mg of Zimura in the study eye administered via IVT injection (or via IVT injection and a Sham administration) on Day 1 and monthly up to 18 months.'}, {'id': 'OG001', 'title': 'Sham [Part 1 & Part 2 Combined]', 'description': 'Participants received a Sham injection (or 2 Sham injections) of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months.'}, {'id': 'OG002', 'title': 'Zimura 4 mg [Part 2]', 'description': 'Participants received 4 mg of Zimura in the study eye administered via 2 IVT injections on Day 1 and monthly up to 18 months.'}, {'id': 'OG003', 'title': 'Sham [Part 2]', 'description': 'Participants received 2 Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.292', 'spread': '0.077', 'groupId': 'OG000'}, {'value': '0.402', 'spread': '0.075', 'groupId': 'OG001'}, {'value': '0.321', 'spread': '0.074', 'groupId': 'OG002'}, {'value': '0.444', 'spread': '0.072', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0072', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.110', 'groupDescription': 'Difference in least squares means between groups calculated as (Sham) minus (Zimura).', 'statisticalMethod': 'Model for repeated measures (MRM)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Model for repeated measures (MRM) and square root transformation was used to compare the treatment groups.'}, {'pValue': '0.0051', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.124', 'groupDescription': 'Difference in least squares means between groups calculated as (Sham) minus (Zimura).', 'statisticalMethod': 'Model for repeated measures (MRM)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Model for repeated measures (MRM) and square root transformation was used to compare treatment groups.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'The least squares mean change in geographic atrophy (GA) from baseline to Month 12 was measured by fundus autofluorescence (FAF). The square root of the GA area was used in the analysis. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for this primary endpoint; the Zimura 1 mg group was for descriptive purposes only.', 'unitOfMeasure': 'millimeters (mm)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was conducted in 2 Parts. The analyses were based on comparisons of Zimura 2mg vs. Sham control and Zimura 4mg vs. Sham control. For comparison of Zimura 2mg vs. Sham control, participants randomized in Part 1 were combined with participants randomized in Part 2. Comparison of Zimura 4mg vs. Sham control was based on participants randomized in Part 2 only.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Best Corrected Visual Acuity Using Early Treatment Diabetic Retinopathy Study Letters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '84', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Zimura 2 mg [Part 1 & Part 2 Combined]', 'description': 'Participants received 2 mg of Zimura in the study eye administered via IVT injection (or via IVT injection and a Sham administration) on Day 1 and monthly up to 18 months.'}, {'id': 'OG001', 'title': 'Sham [Part 1 & Part 2 Combined]', 'description': 'Participants received a Sham injection (or 2 Sham injections) of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months.'}, {'id': 'OG002', 'title': 'Zimura 4 mg [Part 2]', 'description': 'Participants received 4 mg of Zimura in the study eye administered via 2 IVT injections on Day 1 and monthly up to 18 months.'}, {'id': 'OG003', 'title': 'Sham [Part 2]', 'description': 'Participants received 2 Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.90', 'spread': '2.66', 'groupId': 'OG000'}, {'value': '-9.29', 'spread': '2.59', 'groupId': 'OG001'}, {'value': '-3.79', 'spread': '3.11', 'groupId': 'OG002'}, {'value': '-3.51', 'spread': '2.99', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.3464', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.39', 'groupDescription': 'Difference in least squares mean between groups calculated as (Zimura) minus (Sham).', 'statisticalMethod': 'Model for repeated measures (MRM)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Model for repeated measures (MRM) was used to compare the treatment groups.'}, {'pValue': '0.8830', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.28', 'groupDescription': 'Difference in least squares mean between groups calculated as (Zimura) minus (Sham).', 'statisticalMethod': 'Model for repeated measures (MRM)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Model for repeated measures (MRM) was used to compare the treatment groups.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'The least squares mean change in best-corrected visual acuity (BCVA) from baseline to Month 12 was measured using early treatment diabetic retinopathy study \\[ETDRS\\] letters. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for the secondary endpoints; the Zimura 1 mg group was for descriptive purposes only.', 'unitOfMeasure': 'ETDRS Letters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was conducted in 2 Parts. The analyses were based on comparisons of Zimura 2mg vs. Sham control and Zimura 4mg vs. Sham control. For comparison of Zimura 2mg vs. Sham control, participants randomized in Part 1 were combined with participants randomized in Part 2. Comparison of Zimura 4mg vs. Sham control was based on participants randomized in Part 2 only.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Low Luminance BCVA Using Early Treatment Diabetic Retinopathy Study Letters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '84', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Zimura 2 mg [Part 1 & Part 2 Combined]', 'description': 'Participants received 2 mg of Zimura in the study eye administered via IVT injection (or via IVT injection and a Sham administration) on Day 1 and monthly up to 18 months.'}, {'id': 'OG001', 'title': 'Sham [Part 1 & Part 2 Combined]', 'description': 'Participants received a Sham injection (or 2 Sham injections) of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months.'}, {'id': 'OG002', 'title': 'Zimura 4 mg [Part 2]', 'description': 'Participants received 4 mg of Zimura in the study eye administered via 2 IVT injections on Day 1 and monthly up to 18 months.'}, {'id': 'OG003', 'title': 'Sham [Part 2]', 'description': 'Participants received 2 Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.03', 'spread': '3.40', 'groupId': 'OG000'}, {'value': '-1.41', 'spread': '3.30', 'groupId': 'OG001'}, {'value': '1.53', 'spread': '3.53', 'groupId': 'OG002'}, {'value': '2.97', 'spread': '3.39', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.8405', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.38', 'groupDescription': 'Difference in least squares mean between groups calculated as (Zimura) minus (Sham).', 'statisticalMethod': 'Model for repeated measures (MRM)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Model for repeated measures (MRM) was used to compare the treatment groups.'}, {'pValue': '0.5017', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.44', 'groupDescription': 'Difference in least squares mean between groups calculated as (Zimura) minus (Sham).', 'statisticalMethod': 'Model for repeated measures (MRM)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Model for repeated measures (MRM) was used to compare the treatment groups.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'The least squares mean change in low luminance (LL) BCVA from baseline to Month 12 was measured using ETDRS letters. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for the secondary endpoints; the Zimura 1 mg group was for descriptive purposes only.', 'unitOfMeasure': 'ETDRS Letters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was conducted in 2 Parts. The analyses were based on comparisons of Zimura 2mg vs. Sham control and Zimura 4mg vs. Sham control. For comparison of Zimura 2mg vs. Sham control, participants randomized in Part 1 were combined with participants randomized in Part 2. Comparison of Zimura 4mg vs. Sham control was based on participants randomized in Part 2 only.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zimura 1 mg [Part 1]', 'description': 'Participants received 1 mg of Zimura in the study eye administered via intravitreal (IVT) injection on Day 1 and monthly up to 18 months.'}, {'id': 'FG001', 'title': 'Zimura 2 mg [Part 1]', 'description': 'Participants received 2 mg of Zimura in the study eye administered via IVT injection on Day 1 and monthly up to 18 months.'}, {'id': 'FG002', 'title': 'Sham [Part 1]', 'description': 'Participants received a Sham injection of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months.'}, {'id': 'FG003', 'title': 'Zimura 2 mg (Zimura 2mg+Sham) [Part 2]', 'description': 'Participants received 2 mg of Zimura in the study eye administered via IVT injection and a Sham administration on Day 1 and monthly up to 18 months.'}, {'id': 'FG004', 'title': 'Zimura 4 mg (Zimura 2mg+Zimura 2mg) [Part 2]', 'description': 'Participants received 4 mg of Zimura in the study eye administered via 2 IVT injections on Day 1 and monthly up to 18 months.'}, {'id': 'FG005', 'title': 'Sham (Sham+Sham) [Part 2]', 'description': 'Participants received 2 Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '42'}, {'groupId': 'FG004', 'numSubjects': '83'}, {'groupId': 'FG005', 'numSubjects': '84'}]}, {'type': 'Month 12', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '34'}, {'groupId': 'FG004', 'numSubjects': '56'}, {'groupId': 'FG005', 'numSubjects': '72'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '30'}, {'groupId': 'FG004', 'numSubjects': '46'}, {'groupId': 'FG005', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '37'}, {'groupId': 'FG005', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Investigator decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '13'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'Placed in hospice care', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Participant non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Concern over coronavirus disease care', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Study participants are planned to receive 18 monthly intravitreal injections of Zimura and/or Sham in a single designated study eye. The study eye is designated by the Investigator prior to first administration of study drug and does not change throughout the duration of study participation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '83', 'groupId': 'BG004'}, {'value': '84', 'groupId': 'BG005'}, {'value': '286', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Zimura 1 mg [Part 1]', 'description': 'Participants received 1 mg of Zimura in the study eye administered via intravitreal (IVT) injection on Day 1 and monthly up to 18 months.'}, {'id': 'BG001', 'title': 'Zimura 2 mg [Part 1]', 'description': 'Participants received 2 mg of Zimura in the study eye administered via IVT injection on Day 1 and monthly up to 18 months.'}, {'id': 'BG002', 'title': 'Sham [Part 1]', 'description': 'Participants received a Sham injection of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months.'}, {'id': 'BG003', 'title': 'Zimura 2 mg (Zimura 2mg+Sham) [Part 2]', 'description': 'Participants received 2 mg of Zimura in the study eye administered via IVT injection and a Sham administration on Day 1 and monthly up to 18 months.'}, {'id': 'BG004', 'title': 'Zimura 4 mg (Zimura 2mg+Zimura 2mg) [Part 2]', 'description': 'Participants received 4 mg of Zimura in the study eye administered via 2 IVT injections on Day 1 and monthly up to 18 months.'}, {'id': 'BG005', 'title': 'Sham (Sham+Sham) [Part 2]', 'description': 'Participants received 2 Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '78', 'groupId': 'BG004'}, {'value': '80', 'groupId': 'BG005'}, {'value': '262', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}, {'value': '61', 'groupId': 'BG005'}, {'value': '197', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '89', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '82', 'groupId': 'BG004'}, {'value': '83', 'groupId': 'BG005'}, {'value': '281', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '82', 'groupId': 'BG004'}, {'value': '82', 'groupId': 'BG005'}, {'value': '281', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-28', 'size': 1175387, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-01-31T09:29', 'hasProtocol': True}, {'date': '2019-07-19', 'size': 677465, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-01-31T09:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'The Reading Center team and Sponsor were also masked.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 286}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'dispFirstSubmitDate': '2020-09-30', 'completionDateStruct': {'date': '2020-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-25', 'studyFirstSubmitDate': '2016-02-16', 'dispFirstSubmitQcDate': '2020-10-07', 'resultsFirstSubmitDate': '2023-01-27', 'studyFirstSubmitQcDate': '2016-02-18', 'dispFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-18', 'studyFirstPostDateStruct': {'date': '2016-02-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence', 'timeFrame': 'Baseline and 12 months', 'description': 'The least squares mean change in geographic atrophy (GA) from baseline to Month 12 was measured by fundus autofluorescence (FAF). The square root of the GA area was used in the analysis. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for this primary endpoint; the Zimura 1 mg group was for descriptive purposes only.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Best Corrected Visual Acuity Using Early Treatment Diabetic Retinopathy Study Letters', 'timeFrame': 'Baseline and 12 months', 'description': 'The least squares mean change in best-corrected visual acuity (BCVA) from baseline to Month 12 was measured using early treatment diabetic retinopathy study \\[ETDRS\\] letters. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for the secondary endpoints; the Zimura 1 mg group was for descriptive purposes only.'}, {'measure': 'Change From Baseline in Low Luminance BCVA Using Early Treatment Diabetic Retinopathy Study Letters', 'timeFrame': 'Baseline and 12 months', 'description': 'The least squares mean change in low luminance (LL) BCVA from baseline to Month 12 was measured using ETDRS letters. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for the secondary endpoints; the Zimura 1 mg group was for descriptive purposes only.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Geographic Atrophy (GA)', 'Dry age-related macular degeneration', 'AMD', 'Zimura (previous name)', 'Anti-inflammatory', 'complement factor C5 inhibitor', 'ARC1905', 'avacincaptad pegol'], 'conditions': ['Geographic Atrophy', 'Dry Age-Related Macular Degeneration']}, 'referencesModule': {'references': [{'pmid': '32882310', 'type': 'RESULT', 'citation': 'Jaffe GJ, Westby K, Csaky KG, Mones J, Pearlman JA, Patel SS, Joondeph BC, Randolph J, Masonson H, Rezaei KA. C5 Inhibitor Avacincaptad Pegol for Geographic Atrophy Due to Age-Related Macular Degeneration: A Randomized Pivotal Phase 2/3 Trial. Ophthalmology. 2021 Apr;128(4):576-586. doi: 10.1016/j.ophtha.2020.08.027. Epub 2020 Sep 1.'}, {'pmid': '39538001', 'type': 'DERIVED', 'citation': 'Corradetti G, Karamat A, Srinivas S, Lindenberg S, Velaga SB, Corvi F, Attiku Y, Nittala MG, Desai D, Zhu L, Abulon D, Sadda SR. Progression to complete retinal pigment epithelium and outer retinal atrophy (cRORA): post hoc analysis of the GATHER1 trial. Graefes Arch Clin Exp Ophthalmol. 2025 Mar;263(3):669-677. doi: 10.1007/s00417-024-06676-7. Epub 2024 Nov 14.'}, {'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.trialsummaries.com/Study/StudyDetails?id=26398&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 were to evaluate the safety and efficacy of Zimura intravitreal (IVT) administration when administered in participants with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).', 'detailedDescription': 'Participants will receive monthly intravitreal injections of Zimura or Sham for 18 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants of either gender aged ≥ 50 years\n* Diagnosis of Non-foveal GA secondary to dry AMD\n\nExclusion Criteria:\n\n* Evidence of Choroidal Neovascularization (CNV)\n* GA secondary to any condition other than AMD\n* Any prior treatment for AMD 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 three (3) months of trial entry\n* Any prior thermal laser in the macular region, regardless of indication\n* Any ocular or periocular infection in the twelve (12) weeks\n* Previous therapeutic radiation in the region of the study eye\n* Any sign of diabetic retinopathy in either eye'}, 'identificationModule': {'nctId': 'NCT02686658', 'briefTitle': 'Zimura in Participants With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase 2/3 Randomized, Double-Masked, Controlled Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura™ (Anti-C5 Aptamer) in Patients With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration', 'orgStudyIdInfo': {'id': 'OPH2003'}, 'secondaryIdInfos': [{'id': '2015-003991-56', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Avacincaptad Pegol 1 mg [Part 1]', 'description': 'Participants received 1 mg of Avacincaptad Pegol in the study eye administered via IVT injection (50 µL) on Day 1 and monthly up to 18 months.', 'interventionNames': ['Drug: Avacincaptad Pegol']}, {'type': 'EXPERIMENTAL', 'label': 'Avacincaptad Pegol 2 mg [Part 1]', 'description': 'Participants received 2 mg of Avacincaptad Pegol in the study eye administered via IVT injection (100 µL) on Day 1 and monthly up to 18 months.', 'interventionNames': ['Drug: Avacincaptad Pegol']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham [Part 1]', 'description': 'Participants received a Sham injection of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months.', 'interventionNames': ['Other: Sham']}, {'type': 'EXPERIMENTAL', 'label': 'Avacincaptad Pegol 2 mg (Avacincaptad Pegol 2mg+Sham) [Part 2]', 'description': 'Participants received 2 mg of Avacincaptad Pegol in the study eye administered via IVT injection (100 µL) and a subsequent Sham administration on Day 1 and monthly up to 18 months.', 'interventionNames': ['Drug: Avacincaptad Pegol', 'Other: Sham']}, {'type': 'EXPERIMENTAL', 'label': 'Avacincaptad Pegol 4 mg (Avacincaptad Pegol 2mg+Avacincaptad Pegol 2mg) [Part 2]', 'description': 'Participants received 4 mg of Avacincaptad Pegol in the study eye administered via two consecutive IVT injections (2 x 100 µL) on Day 1 and monthly up to 18 months.', 'interventionNames': ['Drug: Avacincaptad Pegol']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham (Sham+Sham) [Part 2]', 'description': 'Participants received two consecutive Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.', 'interventionNames': ['Other: Sham']}], 'interventions': [{'name': 'Avacincaptad Pegol', 'type': 'DRUG', 'otherNames': ['Zimura (previous name)', 'IZERVAY', 'ARC1905'], 'description': 'Avacincaptad Pegol 20 mg/mL solution for intravitreal (IVT) injection', 'armGroupLabels': ['Avacincaptad Pegol 1 mg [Part 1]', 'Avacincaptad Pegol 2 mg (Avacincaptad Pegol 2mg+Sham) [Part 2]', 'Avacincaptad Pegol 2 mg [Part 1]', 'Avacincaptad Pegol 4 mg (Avacincaptad Pegol 2mg+Avacincaptad Pegol 2mg) [Part 2]']}, {'name': 'Sham', 'type': 'OTHER', 'description': 'The Sham procedure included the blunt opening of an empty, needleless syringe barrel placed on the conjunctiva in the inferotemporal quadrant of the eyeball to simulate the pressure of an injection.', 'armGroupLabels': ['Avacincaptad Pegol 2 mg (Avacincaptad Pegol 2mg+Sham) [Part 2]', 'Sham (Sham+Sham) [Part 2]', 'Sham [Part 1]']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85053', 'city': 'Phoenix', 'state': 'Arizona', 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'Israel', 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'zip': '4941492', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Rabin Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '76100', 'city': 'Rehovot', 'country': 'Israel', 'facility': 'Kaplan Medical Center', 'geoPoint': {'lat': 31.89421, 'lon': 34.81199}}, {'zip': '6423906', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Tel-Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': 'LV1002', 'city': 'Riga', 'country': 'Latvia', 'facility': 'Pauls Stradins Clinical University Hospital', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IVERIC bio, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}