Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT05571267
Status:
TERMINATED
Last Update Posted:
2025-03-13
First Post:
2022-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety Study of Zimura in Combination With Anti-VEGF Therapy in Patients With Neovascular AMD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000069579', 'term': 'Ranibizumab'}, {'id': 'C533178', 'term': 'aflibercept'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, '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}, 'limitationsAndCaveats': {'description': "Following the Sponsor's reassessment of the Zimura development program, enrollment was stopped in this trial as the Sponsor determined that they would initiate a new Zimura wet AMD trial, the OPH2007 trial, for treatment-naïve patients. Therefore, a total of two patients were screened, one of whom was a screen failure. Thus, only one patient was enrolled into Study OPH2004."}}, 'adverseEventsModule': {'timeFrame': 'Starting on Day 1, after first dose of trial 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.', 'description': 'Only one patient was enrolled into Study OPH2004. This participant was included in the Zimura and Avastin treatment arm. There were no participants included in the Zimura and Lucentis arm and there were no participants included in the Zimura and Eylea arm.', 'eventGroups': [{'id': 'EG000', 'title': 'Zimura and Avastin', 'description': 'Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Avastin and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Avastin: Avastin 1.25 mg, administered by intravitreal injection', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Zimura and Lucentis', 'description': 'Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Lucentis and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Lucentis: Lucentis 0.5 mg, administered by intravitreal injection', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Zimura and Eylea', 'description': 'Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Eylea and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Eylea: Eylea 2 mg, administered by intravitreal injection', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With >0 Letter Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Zimura and Avastin', 'description': 'Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Avastin and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Avastin: Avastin 1.25 mg, administered by intravitreal injection'}, {'id': 'OG001', 'title': 'Zimura and Lucentis', 'description': 'Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Lucentis and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Lucentis: Lucentis 0.5 mg, administered by intravitreal injection'}, {'id': 'OG002', 'title': 'Zimura and Eylea', 'description': 'Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Eylea and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Eylea: Eylea 2 mg, administered by intravitreal injection'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Vision testing is performed using retroilluminated modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 4 meters. Observed VA loss at Month 12 from Day 1 was assessed.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only one patient was enrolled into Study OPH2004. This participant was included in the Zimura and Avastin arm. There were no participants in the Zimura and Lucentis arm and there were no participants in the Zimura and Eylea arm.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With >0 Letter Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Zimura and Avastin', 'description': 'Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Avastin and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Avastin: Avastin 1.25 mg, administered by intravitreal injection'}, {'id': 'OG001', 'title': 'Zimura and Lucentis', 'description': 'Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Lucentis and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Lucentis: Lucentis 0.5 mg, administered by intravitreal injection'}, {'id': 'OG002', 'title': 'Zimura and Eylea', 'description': 'Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Eylea and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Eylea: Eylea 2 mg, administered by intravitreal injection'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 18', 'description': 'Vision testing is performed using retroilluminated modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 4 meters. Observed VA loss at Month 18 from Day 1 was assessed.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only one patient was enrolled into Study OPH2004. This participant was included in the Zimura and Avastin arm. There were no participants in the Zimura and Lucentis arm and there were no participants in the Zimura and Eylea arm.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With >5 Letter Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Zimura and Avastin', 'description': 'Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Avastin and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Avastin: Avastin 1.25 mg, administered by intravitreal injection'}, {'id': 'OG001', 'title': 'Zimura and Lucentis', 'description': 'Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Lucentis and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Lucentis: Lucentis 0.5 mg, administered by intravitreal injection'}, {'id': 'OG002', 'title': 'Zimura and Eylea', 'description': 'Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Eylea and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Eylea: Eylea 2 mg, administered by intravitreal injection'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 12 from Day 1 was assessed.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only one patient was enrolled into Study OPH2004. This participant was included in the Zimura and Avastin arm. There were no participants in the Zimura and Lucentis arm and there were no participants in the Zimura and Eylea arm.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With >5 Letter Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Zimura and Avastin', 'description': 'Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Avastin and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Avastin: Avastin 1.25 mg, administered by intravitreal injection'}, {'id': 'OG001', 'title': 'Zimura and Lucentis', 'description': 'Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Lucentis and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Lucentis: Lucentis 0.5 mg, administered by intravitreal injection'}, {'id': 'OG002', 'title': 'Zimura and Eylea', 'description': 'Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Eylea and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Eylea: Eylea 2 mg, administered by intravitreal injection'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 18', 'description': 'Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 18 from Day 1 was assessed.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only one patient was enrolled into Study OPH2004. This participant was included in the Zimura and Avastin arm. There were no participants in the Zimura and Lucentis arm and there were no participants in the Zimura and Eylea arm.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With >10 Letter Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Zimura and Avastin', 'description': 'Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Avastin and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Avastin: Avastin 1.25 mg, administered by intravitreal injection'}, {'id': 'OG001', 'title': 'Zimura and Lucentis', 'description': 'Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Lucentis and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Lucentis: Lucentis 0.5 mg, administered by intravitreal injection'}, {'id': 'OG002', 'title': 'Zimura and Eylea', 'description': 'Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Eylea and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Eylea: Eylea 2 mg, administered by intravitreal injection'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 12 from Day 1 was assessed.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only one patient was enrolled into Study OPH2004. This participant was included in the Zimura and Avastin arm. There were no participants in the Zimura and Lucentis arm and there were no participants in the Zimura and Eylea arm.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With >10 Letter Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Zimura and Avastin', 'description': 'Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Avastin and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Avastin: Avastin 1.25 mg, administered by intravitreal injection'}, {'id': 'OG001', 'title': 'Zimura and Lucentis', 'description': 'Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Lucentis and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Lucentis: Lucentis 0.5 mg, administered by intravitreal injection'}, {'id': 'OG002', 'title': 'Zimura and Eylea', 'description': 'Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Eylea and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Eylea: Eylea 2 mg, administered by intravitreal injection'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 18', 'description': 'Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 18 from Day 1 was assessed.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only one patient was enrolled into Study OPH2004. This participant was included in the Zimura and Avastin arm. There were no participants in the Zimura and Lucentis arm and there were no participants in the Zimura and Eylea arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zimura and Avastin', 'description': 'Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Avastin and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Avastin: Avastin 1.25 mg, administered by intravitreal injection'}, {'id': 'FG001', 'title': 'Zimura and Lucentis', 'description': 'Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Lucentis and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Lucentis: Lucentis 0.5 mg, administered by intravitreal injection'}, {'id': 'FG002', 'title': 'Zimura and Eylea', 'description': 'Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Eylea and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Eylea: Eylea 2 mg, administered by intravitreal injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Zimura and Avastin', 'description': 'Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Avastin and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Avastin: Avastin 1.25 mg, administered by intravitreal injection'}, {'id': 'BG001', 'title': 'Zimura and Lucentis', 'description': 'Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Lucentis and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Lucentis: Lucentis 0.5 mg, administered by intravitreal injection'}, {'id': 'BG002', 'title': 'Zimura and Eylea', 'description': 'Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Eylea and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Eylea: Eylea 2 mg, administered by intravitreal injection'}, {'id': 'BG003', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': "Following the Sponsor's reassessment of the Zimura development program, enrollment was stopped in this trial as the Sponsor determined that they would initiate a new Zimura wet AMD trial, the OPH2007 trial, for treatment-naïve patients. Therefore, a total of two patients were screened, one of whom was a screen failure. Thus, only one patient was enrolled into Study OPH2004."}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-22', 'size': 1391639, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-16T15:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Following Sponsor reassessment, OPH2004 enrollment was stopped to initiate a new Zimura wet AMD trial, OPH2007, for treatment-naïve patients. Thus, only one patient was enrolled into and completed Study OPH2004.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2022-09-28', 'resultsFirstSubmitDate': '2023-01-23', 'studyFirstSubmitQcDate': '2022-10-04', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-31', 'studyFirstPostDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With >0 Letter Loss', 'timeFrame': 'Month 12', 'description': 'Vision testing is performed using retroilluminated modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 4 meters. Observed VA loss at Month 12 from Day 1 was assessed.'}, {'measure': 'Percentage of Participants With >0 Letter Loss', 'timeFrame': 'Month 18', 'description': 'Vision testing is performed using retroilluminated modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 4 meters. Observed VA loss at Month 18 from Day 1 was assessed.'}, {'measure': 'Percentage of Participants With >5 Letter Loss', 'timeFrame': 'Month 12', 'description': 'Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 12 from Day 1 was assessed.'}, {'measure': 'Percentage of Participants With >5 Letter Loss', 'timeFrame': 'Month 18', 'description': 'Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 18 from Day 1 was assessed.'}, {'measure': 'Percentage of Participants With >10 Letter Loss', 'timeFrame': 'Month 12', 'description': 'Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 12 from Day 1 was assessed.'}, {'measure': 'Percentage of Participants With >10 Letter Loss', 'timeFrame': 'Month 18', 'description': 'Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 18 from Day 1 was assessed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neovascular age-related macular degeneration (NVAMD)'], 'conditions': ['Neovascular Age-Related Macular Degeneration']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.trialsummaries.com/Study/StudyDetails?id=26399&tenant=MT_AST_9011', 'label': 'Link to plain language summary of the study on the Trial Results Summaries website'}, {'url': 'https://www.clinicaltrials.astellas.com/study/OPH2004/', 'label': 'Link to results and other applicable study documents on the Astellas Clinical Trials website'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to assess the safety of intravitreal (IVT) Zimura® administered in combination with anti-VEGF Therapy (AVASTIN®, EYLEA®, OR LUCENTIS®) in anti-VEGF treatment experienced subjects with neovascular age-related macular degeneration (AMD)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treatment experienced subjects defined as subjects with 1 prior dose of same intravitreal anti-VEGF therapy given within the past 8 weeks for neovascular age-related macular degeneration (NVAMD) in the study eye. There must be \\< 0 letters of improvement in Snellen (not ETDRS Snellen equivalent) visual acuity since the start of anti-VEGF treatment.\n* Presence of subfoveal active choroidal neovascularization (CNV)\n\nExclusion Criteria:\n\n* Intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication, with the exception of the 1 prior anti-VEGF injections.\n* Presence of other causes of choroidal neovascularization, including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.\n* Non-pharmacologic treatment (intraocular surgery or thermal laser) within three months of trial entry.\n* Prior thermal laser in the macular region, regardless of indication.\n* Ocular or periocular infection in the past twelve weeks.\n* History of any of the following conditions or procedures in the study eye: rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery, glaucoma drainage device, or corneal transplant.\n* Previous therapeutic radiation in the region of the study eye.\n* Evidence of diabetic retinopathy'}, 'identificationModule': {'nctId': 'NCT05571267', 'briefTitle': 'Safety Study of Zimura in Combination With Anti-VEGF Therapy in Patients With Neovascular AMD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase 2A Randomized Open-Label Controlled Trial to Assess the Safety of Zimura™ (Anti-C5 Aptamer) Administered in Combination With Anti-VEGF Therapy in Treatment Experienced Patients With Neovascular Age-Related Macular Degeneration', 'orgStudyIdInfo': {'id': 'OPH2004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Avacincaptad Pegol and Avastin', 'description': 'Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Avacincaptad Pegol administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Avastin and Avacincaptad Pegol.', 'interventionNames': ['Drug: Avacincaptad Pegol', 'Drug: Avastin']}, {'type': 'EXPERIMENTAL', 'label': 'Avacincaptad Pegol and Lucentis', 'description': 'Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Avacincaptad Pegol administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Lucentis and Avacincaptad Pegol.', 'interventionNames': ['Drug: Avacincaptad Pegol', 'Drug: Lucentis']}, {'type': 'EXPERIMENTAL', 'label': 'Avacincaptad Pegol and Eylea', 'description': 'Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Avacincaptad Pegol administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Eylea and Avacincaptad Pegol.', 'interventionNames': ['Drug: Avacincaptad Pegol', 'Drug: Eylea']}], 'interventions': [{'name': 'Avacincaptad Pegol', 'type': 'DRUG', 'otherNames': ['Zimura (previous name)', 'IZERVAY', 'ARC1905'], 'description': 'Zimura 2 mg, administered by intravitreal injection', 'armGroupLabels': ['Avacincaptad Pegol and Avastin', 'Avacincaptad Pegol and Eylea', 'Avacincaptad Pegol and Lucentis']}, {'name': 'Avastin', 'type': 'DRUG', 'otherNames': ['Bevacizumab'], 'description': 'Avastin 1.25 mg, administered by intravitreal injection', 'armGroupLabels': ['Avacincaptad Pegol and Avastin']}, {'name': 'Lucentis', 'type': 'DRUG', 'otherNames': ['Ranibizumab'], 'description': 'Lucentis 0.5 mg, administered by intravitreal injection', 'armGroupLabels': ['Avacincaptad Pegol and Lucentis']}, {'name': 'Eylea', 'type': 'DRUG', 'otherNames': ['Aflibercept'], 'description': 'Eylea 2 mg, administered by intravitreal injection', 'armGroupLabels': ['Avacincaptad Pegol and Eylea']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IVERIC bio, Inc.'}]}, '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'}}}}