Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 4:44 PM
Study NCT ID:
NCT07230834
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravitreal (IVT) Pozelimab for Geographic Atrophy (GA) in Adult Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057092', 'term': 'Geographic Atrophy'}, {'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Part A will not be masked (Open label) and part B is masked'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-07-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-13', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-07-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of ocular Treatment-Emergent Adverse Event (TEAEs) in the study eye', 'timeFrame': 'Through week 8', 'description': 'Part A'}, {'measure': 'Occurrence of ocular TEAEs in the study eye', 'timeFrame': 'Through week 16', 'description': 'Part B'}, {'measure': 'Occurrence of systemic TEAEs', 'timeFrame': 'Through week 8', 'description': 'Part A'}, {'measure': 'Occurrence of systemic TEAEs', 'timeFrame': 'Through week 16', 'description': 'Part B'}], 'secondaryOutcomes': [{'measure': 'Concentrations of pozelimab in serum', 'timeFrame': 'Through week 8', 'description': 'Part A'}, {'measure': 'Concentrations of pozelimab in serum', 'timeFrame': 'Through week 16', 'description': 'Part B'}, {'measure': 'Occurrence of Anti-Drug Antibody (ADA) to pozelimab', 'timeFrame': 'Through week 8', 'description': 'Part A'}, {'measure': 'Magnitude of ADA to pozelimab', 'timeFrame': 'Through week 8', 'description': 'Part A'}, {'measure': 'Occurrence of ADA to pozelimab', 'timeFrame': 'Through week 16', 'description': 'Part B'}, {'measure': 'Magnitude of ADA to pozelimab', 'timeFrame': 'Through week 16', 'description': 'Part B'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Age-related Macular Degeneration (AMD)', 'GA secondary to AMD'], 'conditions': ['Geographic Atrophy (GA)']}, 'descriptionModule': {'briefSummary': 'This study is researching an experimental drug called pozelimab (called "study drug"). The study is focused on people with a condition where certain parts of the eye\'s retina stop working over time, which can make it harder to see. This is called geographic atrophy (GA).\n\nThe aim of the study is to see how safe and tolerable the study drug is when used as an injection in the eye.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug\n* How much study drug is in the blood and the fluid in the eye at different times\n* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Study eye with diagnosis of GA of the macula secondary to AMD, as determined by the investigator\n2. Study eye with total GA area measuring approximately one disc area or greater in size (2.5 mm\\^2 or larger) at screening, as determined by the Central Reading Center (CRC), as described in the protocol\n3. Best-Corrected Visual Acuity (BCVA) of 60 letters or worse using the Early Treatment Diabetic Retinopathy Score (ETDRS) charts (Snellen equivalent of \\~ ≤20/63) in the study eye at screening and baseline visit\n\nKey Exclusion Criteria:\n\n1. GA (macular atrophy) in either eye due to causes other than dry AMD\n2. History or current evidence of macular neovascularization and/or retinal exudation in either eye\n3. Concurrent eye disease (elevated Intraocular Pressure (IOP) \\>25mm Hg, diabetic retinopathy, ocular infections/inflammation)\n4. Prior or current intravitreal (IVT) treatment of any kind for any indication in either the study or fellow eye, except complement inhibitor therapy for GA, as long as last dose was ≥3 months prior to screening\n5. Any prior systemic treatment for dry AMD, except oral supplements or vitamins\n6. History or current use of systemic complement inhibitor therapy\n\nNote: Other protocol-defined Inclusion/ Exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT07230834', 'acronym': 'VIENNA', 'briefTitle': 'Intravitreal (IVT) Pozelimab for Geographic Atrophy (GA) in Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Phase 1 Dose-Escalation and Repeated-Dose Study of the Safety and Tolerability of Intravitreal Pozelimab in Participants With Geographic Atrophy', 'orgStudyIdInfo': {'id': 'R3918-AMD-2501'}, 'secondaryIdInfos': [{'id': '2025-521758-40-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A', 'interventionNames': ['Drug: Pozelimab']}, {'type': 'EXPERIMENTAL', 'label': 'Part B', 'interventionNames': ['Drug: Pozelimab']}], 'interventions': [{'name': 'Pozelimab', 'type': 'DRUG', 'otherNames': ['REGN3918'], 'description': 'Administered per the protocol', 'armGroupLabels': ['Part A', 'Part B']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Clinical Trials Administrator', 'role': 'CONTACT', 'email': 'clinicaltrials@regeneron.com', 'phone': '844-734-6643'}], 'overallOfficials': [{'name': 'Clinical Trial Management', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regeneron Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'When Regeneron has:\n\n* received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development\n* made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)\n* the legal authority to share the data, and\n* ensured the ability to protect participant privacy', 'ipdSharing': 'YES', 'description': 'All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing', 'accessCriteria': "Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}