Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-02-28 @ 2:11 PM
Study NCT ID:
NCT02503332
Status:
COMPLETED
Last Update Posted:
2020-10-06
First Post:
2015-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Pegcetacoplan (APL-2) Therapy in Patients With Geographic Atrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057092', 'term': 'Geographic Atrophy'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000716074', 'term': 'pegcetacoplan'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@apellis.com', 'phone': '1-833-284-6361', 'title': 'Apellis Clinical Trial Information Line', 'organization': 'Apellis Pharmaceuticals, Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'TEAE data is reported from the time of first study drug administration (Day 1) up to Month 12 (Data cut-off date).', 'description': 'The safety population included all randomized subjects who received at least one injection of study drug.\n\nOcular TEAEs are presented separately for the study and fellow eyes, and non-ocular (systemic) TEAEs are also presented.', 'eventGroups': [{'id': 'EG000', 'title': 'Pegcetacoplan Monthly: Ocular Study Eye', 'description': 'Ocular TEAEs are summarized for the study eye for all subjects who received IVT injections of pegcetacoplan 15 mg/100 μL once monthly for 12 months.', 'otherNumAtRisk': 86, 'deathsNumAtRisk': 86, 'otherNumAffected': 51, 'seriousNumAtRisk': 86, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Pegcetacoplan EOM: Ocular Study Eye', 'description': 'Ocular TEAEs are summarized for the study eye for all subjects who received IVT injections of pegcetacoplan 15 mg/100 μL EOM for 12 months.', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 35, 'seriousNumAtRisk': 79, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Sham Pooled: Ocular Study Eye', 'description': 'Ocular TEAEs are summarized for the study eye for all subjects who randomized to sham monthly and sham EOM treatment groups.\n\nSham Monthly: Subjects received sham injections once monthly for 12 months.\n\nSham EOM: Subjects received sham injections EOM for 12 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 25, 'seriousNumAtRisk': 81, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Pegcetacoplan Monthly: Ocular Fellow Eye', 'description': 'Ocular TEAEs are summarized for the fellow eye for all subjects who received IVT injections of pegcetacoplan 15 mg/100 μL once monthly for 12 months.', 'otherNumAtRisk': 86, 'deathsNumAtRisk': 86, 'otherNumAffected': 12, 'seriousNumAtRisk': 86, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Pegcetacoplan EOM: Ocular Fellow Eye', 'description': 'Ocular TEAEs are summarized for the fellow eye for all subjects who received IVT injections of pegcetacoplan 15 mg/100 μL EOM for 12 months.', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 8, 'seriousNumAtRisk': 79, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Sham Pooled: Ocular Fellow Eye', 'description': 'Ocular TEAEs are summarized for the fellow eye for all subjects who randomized to sham monthly and sham EOM treatment groups.\n\nSham Monthly: Subjects received sham injections once monthly for 12 months.\n\nSham EOM: Subjects received sham injections EOM for 12 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 10, 'seriousNumAtRisk': 81, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Pegcetacoplan Monthly: Non-ocular', 'description': 'Non-ocular (systemic) TEAEs are summarized for all subjects who received IVT injections of pegcetacoplan 15 mg/100 μL once monthly for 12 months.', 'otherNumAtRisk': 86, 'deathsNumAtRisk': 86, 'otherNumAffected': 23, 'seriousNumAtRisk': 86, 'deathsNumAffected': 0, 'seriousNumAffected': 12}, {'id': 'EG007', 'title': 'Pegcetacoplan EOM: Non-ocular', 'description': 'Non-ocular (systemic) TEAEs are summarized for all subjects who received IVT injections of pegcetacoplan 15 mg/100 μL EOM for 12 months.', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 18, 'seriousNumAtRisk': 79, 'deathsNumAffected': 2, 'seriousNumAffected': 23}, {'id': 'EG008', 'title': 'Sham Pooled: Non-ocular', 'description': 'Non-ocular (systemic) TEAEs are summarized for all subjects who randomized to sham monthly and sham EOM treatment groups.\n\nSham Monthly: Subjects received sham injections once monthly for 12 months.\n\nSham EOM: Subjects received sham injections EOM for 12 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 23, 'seriousNumAtRisk': 81, 'deathsNumAffected': 2, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Neovascular age-related macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vitreous detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 9}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 9}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 7}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Endophthalmitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dry age-related macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG001', 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[{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Least Square (LS) Mean Change From Baseline in Square Root GA Lesion Size in the Study Eye at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegcetacoplan Monthly', 'description': 'Subjects received IVT injections of pegcetacoplan 15 mg/100 μL once monthly for 12 months.'}, {'id': 'OG001', 'title': 'Pegcetacoplan EOM', 'description': 'Subjects received IVT injections of pegcetacoplan 15 mg/100 μL EOM for 12 months.'}, {'id': 'OG002', 'title': 'Sham Pooled', 'description': 'Sham Monthly: Subjects received sham injections once monthly for 12 months.\n\nSham EOM: Subjects received sham injections EOM for 12 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.26', 'spread': '0.025', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '0.026', 'groupId': 'OG001'}, {'value': '0.35', 'spread': '0.025', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (screening) and Month 12.', 'description': 'The square root GA lesion size (i.e. transformed area of GA) was measured by FAF photographs. Baseline was defined as the last available, non-missing observation prior to first study drug administration.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified ITT (mITT) population included all randomized subjects who received at least one injection of study drug and had at least one visit at or after Month 2 where primary efficacy data was collected. Subjects were included in their randomized treatment group even if they received the wrong study drug.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Treatment Emergent Adverse Events (TEAEs) in the Study Eye, Including by Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegcetacoplan Monthly', 'description': 'Subjects received IVT injections of pegcetacoplan 15 mg/100 μL once monthly for 12 months.'}, {'id': 'OG001', 'title': 'Pegcetacoplan EOM', 'description': 'Subjects received IVT injections of pegcetacoplan 15 mg/100 μL EOM for 12 months.'}, {'id': 'OG002', 'title': 'Sham Pooled', 'description': 'Sham Monthly: Subjects received sham injections once monthly for 12 months.\n\nSham EOM: Subjects received sham injections EOM for 12 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}]}, {'title': 'Treatment-related TEAEs', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'TEAEs with mild intensity', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}, {'title': 'TEAEs with moderate intensity', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'TEAEs with severe intensity', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'TEAEs with life-threatening intensity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Death related to TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'TEAESIs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'TEAEs leading to study/treatment discontinuation', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the time of first study drug administration (Day 1) up to Month 12 (Data cut-off date).', 'description': 'A TEAE was defined as any adverse event (AE) that commenced or worsened on or after time of first study drug administration up to 60 days beyond last dose of study drug. A treatment-related TEAE was defined as a TEAE with a relationship to study drug of possibly related or probably related or not reported. Severity of TEAEs were categorized as mild; moderate; severe; life-threatening or death related to TEAE, according to Common Terminology Criteria for AEs v4.03. A TEAE of special interest (TEAESI) was defined as a TEAE of scientific and medical concern specific to pegcetacoplan, whether serious or non-serious.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all randomized subjects who received at least one injection of study drug.'}, {'type': 'SECONDARY', 'title': 'LS Mean Change From Baseline in Untransformed GA Lesion Size in the Study Eye at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegcetacoplan Monthly', 'description': 'Subjects received IVT injections of pegcetacoplan 15 mg/100 μL once monthly for 12 months.'}, {'id': 'OG001', 'title': 'Pegcetacoplan EOM', 'description': 'Subjects received IVT injections of pegcetacoplan 15 mg/100 μL EOM for 12 months.'}, {'id': 'OG002', 'title': 'Sham Pooled', 'description': 'Sham Monthly: Subjects received sham injections once monthly for 12 months.\n\nSham EOM: Subjects received sham injections EOM for 12 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.49', 'spread': '0.161', 'groupId': 'OG000'}, {'value': '1.69', 'spread': '0.168', 'groupId': 'OG001'}, {'value': '2.12', 'spread': '0.161', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) and Month 12.', 'description': 'The untransformed area of GA was measured by FAF. Baseline is defined as the last available, non-missing observation prior to first study drug administration.', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all randomized subjects who received at least one injection of study drug and had at least one visit at or after Month 2 where primary efficacy data was collected. Subjects were included in their randomized treatment group even if they received the wrong study drug.'}, {'type': 'SECONDARY', 'title': 'LS Mean Change From Baseline in Best-Corrected Visual Acuity (BCVA) Score of the Study Eye at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegcetacoplan Monthly', 'description': 'Subjects received IVT injections of pegcetacoplan 15 mg/100 μL once monthly for 12 months.'}, {'id': 'OG001', 'title': 'Pegcetacoplan EOM', 'description': 'Subjects received IVT injections of pegcetacoplan 15 mg/100 μL EOM for 12 months.'}, {'id': 'OG002', 'title': 'Sham Pooled', 'description': 'Sham Monthly: Subjects received sham injections once monthly for 12 months.\n\nSham EOM: Subjects received sham injections EOM for 12 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.31', 'spread': '1.352', 'groupId': 'OG000'}, {'value': '-5.78', 'spread': '1.398', 'groupId': 'OG001'}, {'value': '-4.36', 'spread': '1.364', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) and Month 12.', 'description': 'The BCVA letter score was determined using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. The score ranges from 0 to 100 letters, lower number indicating reduced visual acuity; a positive value of change from baseline indicates visual acuity gain and a negative value indicates visual acuity loss.', 'unitOfMeasure': 'ETDRS letter score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all randomized subjects who received at least one injection of study drug and had at least one visit at or after Month 2 where primary efficacy data was collected. Subjects were included in their randomized treatment group even if they received the wrong study drug.'}, {'type': 'SECONDARY', 'title': 'LS Mean Change From Baseline in Low Luminance BCVA (LL-BCVA) Score in the Study Eye at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegcetacoplan Monthly', 'description': 'Subjects received IVT injections of pegcetacoplan 15 mg/100 μL once monthly for 12 months.'}, {'id': 'OG001', 'title': 'Pegcetacoplan EOM', 'description': 'Subjects received IVT injections of pegcetacoplan 15 mg/100 μL EOM for 12 months.'}, {'id': 'OG002', 'title': 'Sham Pooled', 'description': 'Sham Monthly: Subjects received sham injections once monthly for 12 months.\n\nSham EOM: Subjects received sham injections EOM for 12 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.73', 'spread': '1.145', 'groupId': 'OG000'}, {'value': '-3.21', 'spread': '1.184', 'groupId': 'OG001'}, {'value': '-0.55', 'spread': '1.150', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) and Month 12.', 'description': 'The LL-BCVA was measured by placing a 2.0-log-unit neutral density filter over the best correction and having the participant read the normally illuminated ETDRS chart. The score ranges from 0 to 100 letters, lower number indicating worse vision; a positive value of change from baseline indicates visual acuity gain and a negative value indicates visual acuity loss.', 'unitOfMeasure': 'ETDRS letter score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all randomized subjects who received at least one injection of study drug and had at least one visit at or after Month 2 where primary efficacy data was collected. Subjects were included in their randomized treatment group even if they received the wrong study drug.'}, {'type': 'SECONDARY', 'title': 'LS Mean Change From Baseline in Low Luminance VA (LL-VA) Deficit Score in the Study Eye at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegcetacoplan Monthly', 'description': 'Subjects received IVT injections of pegcetacoplan 15 mg/100 μL once monthly for 12 months.'}, {'id': 'OG001', 'title': 'Pegcetacoplan EOM', 'description': 'Subjects received IVT injections of pegcetacoplan 15 mg/100 μL EOM for 12 months.'}, {'id': 'OG002', 'title': 'Sham Pooled', 'description': 'Sham Monthly: Subjects received sham injections once monthly for 12 months.\n\nSham EOM: Subjects received sham injections EOM for 12 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.76', 'spread': '1.382', 'groupId': 'OG000'}, {'value': '-2.40', 'spread': '1.424', 'groupId': 'OG001'}, {'value': '-3.72', 'spread': '1.385', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) and Month 12.', 'description': 'The LL-VA deficit score is calculated as BCVA score minus LL-BCVA score. The LL-VA deficit score ranges from 0 to 100 letters, lower number indicating worse deficit.', 'unitOfMeasure': 'ETDRS letter score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all randomized subjects who received at least one injection of study drug and had at least one visit at or after Month 2 where primary efficacy data was collected. Subjects were included in their randomized treatment group even if they received the wrong study drug.'}, {'type': 'SECONDARY', 'title': 'LS Mean Change From Baseline in Distance of GA Lesion From the Fovea (Foveal Encroachment) in the Study Eye at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegcetacoplan Monthly', 'description': 'Subjects received IVT injections of pegcetacoplan 15 mg/100 μL once monthly for 12 months.'}, {'id': 'OG001', 'title': 'Pegcetacoplan EOM', 'description': 'Subjects received IVT injections of pegcetacoplan 15 mg/100 μL EOM for 12 months.'}, {'id': 'OG002', 'title': 'Sham Pooled', 'description': 'Sham Monthly: Subjects received sham injections once monthly for 12 months.\n\nSham EOM: Subjects received sham injections EOM for 12 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.011', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.012', 'groupId': 'OG001'}, {'value': '-0.06', 'spread': '0.011', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) and Month 12.', 'description': 'The foveal encroachment in the study eye was measured by FAF. Baseline is defined as the last available, non-missing observation prior to first study drug administration.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all randomized subjects who received at least one injection of study drug and had at least one visit at or after Month 2 where primary efficacy data was collected. Subjects were included in their randomized treatment group even if they received the wrong study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Macular Neovascularization (MNV) TEAEs in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegcetacoplan Monthly', 'description': 'Subjects received IVT injections of pegcetacoplan 15 mg/100 μL once monthly for 12 months.'}, {'id': 'OG001', 'title': 'Pegcetacoplan EOM', 'description': 'Subjects received IVT injections of pegcetacoplan 15 mg/100 μL EOM for 12 months.'}, {'id': 'OG002', 'title': 'Sham Pooled', 'description': 'Sham Monthly: Subjects received sham injections once monthly for 12 months.\n\nSham EOM: Subjects received sham injections EOM for 12 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the time of first study drug administration (Day 1) up to Month 12 (Data cut-off date).', 'description': 'The number of subjects with any MNV TEAEs in the study eye was identified via clinical review of all ocular TEAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all randomized subjects who received at least one injection of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pegcetacoplan Monthly', 'description': 'Subjects received intravitreal (IVT) injections of pegcetacoplan 15 milligrams (mg)/100 microliters (μL) once monthly for 12 months.'}, {'id': 'FG001', 'title': 'Pegcetacoplan EOM', 'description': 'Subjects received IVT injections of pegcetacoplan 15 mg/100 μL EOM for 12 months.'}, {'id': 'FG002', 'title': 'Sham Monthly', 'description': 'Subjects received sham injections once monthly for 12 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.'}, {'id': 'FG003', 'title': 'Sham EOM', 'description': 'Subjects received sham injections EOM for 12 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '79'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'comment': 'Completed treatment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': "Investigator's Decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': "Sponsor's Decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Subject Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This Phase II, randomized, single-masked, sham injection-controlled study in subjects with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) was conducted at 47 sites (46 active) in 3 countries between 24 September 2015 and 14 July 2017 (Data cut-off date, Month 12).', 'preAssignmentDetails': 'Subjects were randomized in a 2:2:1:1 manner to receive treatment with pegcetacoplan monthly, pegcetacoplan every-other-month (EOM), sham monthly or sham EOM, respectively. A total of 246 subjects were randomized in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '246', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Pegcetacoplan Monthly', 'description': 'Subjects received IVT injections of pegcetacoplan 15 mg/100 μL once monthly for 12 months.'}, {'id': 'BG001', 'title': 'Pegcetacoplan EOM', 'description': 'Subjects received IVT injections of pegcetacoplan 15 mg/100 μL EOM for 12 months.'}, {'id': 'BG002', 'title': 'Sham Pooled', 'description': 'Sham Monthly: Subjects received sham injections once monthly for 12 months.\n\nSham EOM: Subjects received sham injections EOM for 12 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '79.6', 'spread': '7.51', 'groupId': 'BG000'}, {'value': '81.0', 'spread': '7.55', 'groupId': 'BG001'}, {'value': '78.4', 'spread': '7.43', 'groupId': 'BG002'}, {'value': '79.7', 'spread': '7.54', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '154', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '241', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '234', 'groupId': 'BG003'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '201', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'GA Lesion Size (fundus autofluorescence [FAF]) in the Study Eye', 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'spread': '3.84', 'groupId': 'BG000'}, {'value': '8.9', 'spread': '4.47', 'groupId': 'BG001'}, {'value': '8.2', 'spread': '4.05', 'groupId': 'BG002'}, {'value': '8.4', 'spread': '4.12', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'millimeter square (mm^2)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The Intent to Treat (ITT) population included all randomized subjects who received at least one injection of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-01', 'size': 592223, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-07-31T12:31', 'hasProtocol': True}, {'date': '2018-01-29', 'size': 1295012, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-07-31T12:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 246}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'dispFirstSubmitDate': '2019-11-13', 'completionDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-14', 'studyFirstSubmitDate': '2015-07-14', 'dispFirstSubmitQcDate': '2019-11-13', 'resultsFirstSubmitDate': '2020-08-04', 'studyFirstSubmitQcDate': '2015-07-17', 'dispFirstPostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-14', 'studyFirstPostDateStruct': {'date': '2015-07-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Least Square (LS) Mean Change From Baseline in Square Root GA Lesion Size in the Study Eye at Month 12', 'timeFrame': 'Baseline (screening) and Month 12.', 'description': 'The square root GA lesion size (i.e. transformed area of GA) was measured by FAF photographs. Baseline was defined as the last available, non-missing observation prior to first study drug administration.'}, {'measure': 'Number of Subjects With Treatment Emergent Adverse Events (TEAEs) in the Study Eye, Including by Severity', 'timeFrame': 'From the time of first study drug administration (Day 1) up to Month 12 (Data cut-off date).', 'description': 'A TEAE was defined as any adverse event (AE) that commenced or worsened on or after time of first study drug administration up to 60 days beyond last dose of study drug. A treatment-related TEAE was defined as a TEAE with a relationship to study drug of possibly related or probably related or not reported. Severity of TEAEs were categorized as mild; moderate; severe; life-threatening or death related to TEAE, according to Common Terminology Criteria for AEs v4.03. A TEAE of special interest (TEAESI) was defined as a TEAE of scientific and medical concern specific to pegcetacoplan, whether serious or non-serious.'}], 'secondaryOutcomes': [{'measure': 'LS Mean Change From Baseline in Untransformed GA Lesion Size in the Study Eye at Month 12', 'timeFrame': 'Baseline (Day 1) and Month 12.', 'description': 'The untransformed area of GA was measured by FAF. Baseline is defined as the last available, non-missing observation prior to first study drug administration.'}, {'measure': 'LS Mean Change From Baseline in Best-Corrected Visual Acuity (BCVA) Score of the Study Eye at Month 12', 'timeFrame': 'Baseline (Day 1) and Month 12.', 'description': 'The BCVA letter score was determined using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. The score ranges from 0 to 100 letters, lower number indicating reduced visual acuity; a positive value of change from baseline indicates visual acuity gain and a negative value indicates visual acuity loss.'}, {'measure': 'LS Mean Change From Baseline in Low Luminance BCVA (LL-BCVA) Score in the Study Eye at Month 12', 'timeFrame': 'Baseline (Day 1) and Month 12.', 'description': 'The LL-BCVA was measured by placing a 2.0-log-unit neutral density filter over the best correction and having the participant read the normally illuminated ETDRS chart. The score ranges from 0 to 100 letters, lower number indicating worse vision; a positive value of change from baseline indicates visual acuity gain and a negative value indicates visual acuity loss.'}, {'measure': 'LS Mean Change From Baseline in Low Luminance VA (LL-VA) Deficit Score in the Study Eye at Month 12', 'timeFrame': 'Baseline (Day 1) and Month 12.', 'description': 'The LL-VA deficit score is calculated as BCVA score minus LL-BCVA score. The LL-VA deficit score ranges from 0 to 100 letters, lower number indicating worse deficit.'}, {'measure': 'LS Mean Change From Baseline in Distance of GA Lesion From the Fovea (Foveal Encroachment) in the Study Eye at Month 12', 'timeFrame': 'Baseline (Day 1) and Month 12.', 'description': 'The foveal encroachment in the study eye was measured by FAF. Baseline is defined as the last available, non-missing observation prior to first study drug administration.'}, {'measure': 'Number of Subjects With Any Macular Neovascularization (MNV) TEAEs in the Study Eye', 'timeFrame': 'From the time of first study drug administration (Day 1) up to Month 12 (Data cut-off date).', 'description': 'The number of subjects with any MNV TEAEs in the study eye was identified via clinical review of all ocular TEAEs.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Geographic Atrophy']}, 'referencesModule': {'references': [{'pmid': '39522752', 'type': 'DERIVED', 'citation': 'Reiter GS, Lachinov D, Buhl W, Weigert G, Grechenig C, Mai J, Bogunovic H, Schmidt-Erfurth U. A Novel Management Challenge in Age-Related Macular Degeneration: Artificial Intelligence and Expert Prediction of Geographic Atrophy. Ophthalmol Retina. 2025 May;9(5):421-430. doi: 10.1016/j.oret.2024.10.029. Epub 2024 Nov 9.'}, {'pmid': '37715860', 'type': 'DERIVED', 'citation': 'Fu DJ, Lipkova V, Liefers B, Glinton S, Faes L, McKeown A, Scheibler L, Pontikos N, Patel PJ, Zhang G, Keane PA, Balaskas K. Evaluating the Effects of C3 Inhibition on Geographic Atrophy Progression from Deep-Learning OCT Quantification: A Split-Person Study. Ophthalmol Ther. 2023 Dec;12(6):3143-3158. doi: 10.1007/s40123-023-00798-7. Epub 2023 Sep 16.'}, {'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.'}, {'pmid': '36284220', 'type': 'DERIVED', 'citation': 'Pfau M, Schmitz-Valckenberg S, Ribeiro R, Safaei R, McKeown A, Fleckenstein M, Holz FG. Association of complement C3 inhibitor pegcetacoplan with reduced photoreceptor degeneration beyond areas of geographic atrophy. Sci Rep. 2022 Oct 25;12(1):17870. doi: 10.1038/s41598-022-22404-9.'}, {'pmid': '35948209', 'type': 'DERIVED', 'citation': 'Vogl WD, Riedl S, Mai J, Reiter GS, Lachinov D, Bogunovic H, Schmidt-Erfurth U. Predicting Topographic Disease Progression and Treatment Response of Pegcetacoplan in Geographic Atrophy Quantified by Deep Learning. Ophthalmol Retina. 2023 Jan;7(1):4-13. doi: 10.1016/j.oret.2022.08.003. Epub 2022 Aug 7.'}, {'pmid': '35860926', 'type': 'DERIVED', 'citation': 'Liao DS, Metlapally R, Joshi P. Pegcetacoplan treatment for geographic atrophy due to age-related macular degeneration: a plain language summary of the FILLY study. Immunotherapy. 2022 Sep;14(13):995-1006. doi: 10.2217/imt-2022-0078. Epub 2022 Jul 21.'}, {'pmid': '35113137', 'type': 'DERIVED', 'citation': 'Nittala MG, Metlapally R, Ip M, Chakravarthy U, Holz FG, Staurenghi G, Waheed N, Velaga SB, Lindenberg S, Karamat A, Koester J, Ribeiro R, Sadda S. Association of Pegcetacoplan With Progression of Incomplete Retinal Pigment Epithelium and Outer Retinal Atrophy in Age-Related Macular Degeneration: A Post Hoc Analysis of the FILLY Randomized Clinical Trial. JAMA Ophthalmol. 2022 Mar 1;140(3):243-249. doi: 10.1001/jamaophthalmol.2021.6067.'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives of the study are to assess the safety, tolerability and evidence of activity of multiple intravitreal (IVT) injections of pegcetacoplan in subjects with Geographic Atrophy associated with Age-Related Macular Degeneration (AMD).', 'detailedDescription': 'This is a Phase II, prospective, multicenter, randomized, single-masked, sham-controlled study to assess the safety, tolerability and evidence of activity of multiple IVT injections of pegcetacoplan in subjects with GA secondary to Age-Related Macular Degeneration.\n\nThe study will randomize approximately 240 subjects to obtain at least 200 evaluable subjects across 40 multinational sites.\n\nSubjects will be randomized in a 2:2:1:1 manner to receive pegcetacoplan Monthly (AM), pegcetacoplan Every-Other-Month (AEOM), Sham injection Monthly (SM) or Sham injection Every-Other-Month (SEOM), respectively.\n\nAll subjects will return to the clinical site on Day 7 to assess acute safety after the first injection. After that, subjects in the monthly groups will return to the clinical site for additional pegcetacoplan (or Sham) injections and study procedures every month until Month 12. Subjects in the Every-Other-Month groups will return to the clinical site for additional pegcetacoplan (or Sham) injections and study procedures every two months until Month 12. All subjects will return for follow-up visits on Months 15 and 18 (3 and 6 months after last injection, respectively).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Unless specified otherwise, ocular specific inclusion criteria apply to the study eye only.\n\n1. Male or Female.\n2. Age greater than or equal to 50 years.\n3. BCVA of 20/320 (Snellen equivalent) or better using ETDRS charts.\n4. Diagnosis of GA of the macula secondary to age-related macular degeneration, confirmed within 14 days prior to randomization by the central reading center (CRC) using Fundus Autofluorescence (FAF) images, as well as the following criteria:\n\n 1. Total GA area must be ≥ 2.5 and ≤ 17.5 mm2 (1 and 7 disk areas \\[DA\\] respectively), determined by screening images of FAF.\n 2. If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 DA).\n 3. GA can be completely visualized on the macula centered image.\n 4. GA must be able to be photographed in its entirety.\n 5. GA must be able to be measured separately from any areas of peripapillary atrophy as assessed by the CRC.\n 6. Presence of any pattern of hyperautofluorescence in the junctional zone of GA. Absence of hyperautoflouorescence (i.e. pattern = none) is exclusionary. See Holz et al. 2007.1\n5. Female subjects must be:\n\n 1. Women of non-child-bearing potential (WONCBP), or\n 2. Women of child-bearing potential (WOCBP) with a negative pregnancy test at screening and must agree to use protocol defined methods of contraception for the duration of the study.\n6. Males with female partners of child-bearing potential must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study.\n7. Willing and able to give informed consent.\n\nExclusion Criteria: Unless specified otherwise, ocular specific inclusion criteria apply to the study eye only.\n\n1. GA due to causes other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like plaquenil maculopathy.\n2. Spherical equivalent of the refractive error demonstrating \\> 6 diopters of myopia or an axial length \\>26 mm.\n3. Any history or current evidence of exudative ("wet") AMD including any evidence of retinal pigment epithelium rips or evidence of neovascularization anywhere in the retina based on fluorescein angiogram as assessed by the CRC.\n4. Retinal disease other than AMD; however, benign conditions of the vitreous or peripheral retina are not exclusionary (i.e. pavingstone degeneration).\n5. Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the Investigator interferes with ophthalmologic examination (e.g. advanced cataract or corneal abnormalities).\n6. Any ophthalmologic condition that prevents adequate imaging of the retina judged by the site or CRC.\n7. Intraocular surgery (including lens replacement surgery) within 3 months prior to randomization.\n8. Aphakia or absence of the posterior capsule. Previous violation of the posterior capsule is also excluded unless it occurred as a result of yttrium aluminum garnet (YAG) laser posterior capsulotomy in association with prior posterior chamber intraocular lens implantation and at least 60 days prior to Day 0.\n9. Any ophthalmic condition that may require surgery during the study period.\n10. Any contraindication to IVT injection including current ocular or periocular infection.\n11. History of uveitis or endophthalmitis.\n12. History of IVT injection at any time.\n13. Participation in another interventional clinical study, or use of any experimental treatment for AMD or any other investigational new drug within 6 weeks or 5 half-lives of the active (whichever is longer) prior to the start of study treatment. Note: clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary.\n14. Medical or psychiatric conditions that, in the opinion of the investigator, make consistent follow-up over the treatment period unlikely, or in general a poor medical risk because of other systemic diseases or active uncontrolled infections.\n15. Any screening laboratory value (hematology, serum chemistry or urinalysis) that in the opinion of the Investigator is clinically significant and not suitable for study participation.\n16. Hypersensitivity to fluorescein.'}, 'identificationModule': {'nctId': 'NCT02503332', 'acronym': 'FILLY', 'briefTitle': 'Study of Pegcetacoplan (APL-2) Therapy in Patients With Geographic Atrophy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Apellis Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase II, Multicenter, Randomized, Single-Masked, Sham-Controlled Study of Safety, Tolerability and Evidence of Activity of Intravitreal APL-2 Therapy in Patients With Geographic Atrophy (GA)', 'orgStudyIdInfo': {'id': 'POT-CP121614'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pegcetacoplan 15 mg/100 µL Monthly for 12 months', 'description': 'A single dose of 15 mg pegcetacoplan/100 µL will be administered via intravitreal injection in this study. Subjects will receive an injection every month for 12 consecutive months.', 'interventionNames': ['Drug: Pegcetacoplan']}, {'type': 'EXPERIMENTAL', 'label': 'Pegcetacoplan 15 mg/100 µL EOM for 12 months', 'description': 'A single dose of 15 mg pegcetacoplan/100 µL will be administered via intravitreal injection in this study. Subjects will receive an injection every other month (EOM) for 12 consecutive months.', 'interventionNames': ['Drug: Pegcetacoplan']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Monthly for 12 months', 'description': 'Subjects will receive a Sham procedure every month for 12 consecutive months.', 'interventionNames': ['Other: Sham Procedure']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham EOM for 12 months', 'description': 'Subjects will receive a Sham procedure every other month (EOM) for 12 consecutive months.', 'interventionNames': ['Other: Sham Procedure']}], 'interventions': [{'name': 'Pegcetacoplan', 'type': 'DRUG', 'otherNames': ['APL-2'], 'armGroupLabels': ['Pegcetacoplan 15 mg/100 µL EOM for 12 months', 'Pegcetacoplan 15 mg/100 µL Monthly for 12 months']}, {'name': 'Sham Procedure', 'type': 'OTHER', 'armGroupLabels': ['Sham EOM for 12 months', 'Sham Monthly for 12 months']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36606', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Retina Speciality Institute', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85014', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Retinal Research Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Retina Vitreous Asociates Mdical Goup', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'The Gavin Herbert Eye Institute/UC Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California - USC Eye Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94303', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Byers Eye Institute at Stanford, Stanford School of Medicine', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '06320', 'city': 'New London', 'state': 'Connecticut', 'country': 'United States', 'facility': 'New England Retina Associates', 'geoPoint': {'lat': 41.35565, 'lon': -72.09952}}, {'zip': '33426', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Eye Microsurgical Institute, Inc.', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33907', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Retina Health Center', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Bascom Palmer Eye Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'South East Retina', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60426', 'city': 'Harvey', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois Retina Associates', 'geoPoint': {'lat': 41.61003, 'lon': -87.64671}}, {'zip': '46290', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Midwest Eye Institute', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21237', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Elman Research', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ophthalmic Consultants of Boston', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '45946', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Associated Retinal Consultants PC', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '49586', 'city': 'Traverse City', 'state': 'Michigan', 'country': 'United States', 'facility': 'Associated Retinal Consultants, PC', 'geoPoint': {'lat': 44.76306, 'lon': -85.62063}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '03801', 'city': 'Portsmouth', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Eyesight Opthalmic Services PA', 'geoPoint': {'lat': 43.07704, 'lon': -70.75766}}, {'zip': '10022', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Vitreous Retina Macula Consultants of New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28210', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Charlotte Eye Ear Nose and Throat Associates', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University, Duke Eye Center', 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