Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-01-18 @ 12:00 PM
Study NCT ID:
NCT07215234
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-10-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2032-07-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-10-01', 'studyFirstSubmitQcDate': '2025-10-09', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-10-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of ocular and non-ocular treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Day 1 to Week 104'}, {'measure': 'Incidence and severity of ocular and non-ocular treatment-emergent serious adverse events (TESAEs)', 'timeFrame': 'Day 1 to Week 104'}], 'secondaryOutcomes': [{'measure': 'Change in square root-transformed (mm) and untransformed area (mm2) of GA', 'timeFrame': 'Baseline, Week 52, Week 104'}, {'measure': 'Change in best-corrected visual acuity (BCVA) from baseline to Week 52 and Week 104 following SAR446597 administration measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart', 'timeFrame': 'Baseline, Week 52, Week 104'}, {'measure': 'Percentage of participants without loss of BCVA of ≥15 ETDRS letters from baseline in the study eye', 'timeFrame': 'Baseline, Week 52, Week 104'}, {'measure': 'Incidence and severity of ocular and non-ocular TEAEs and TESAEs including clinically significant changes in safety parameters', 'timeFrame': 'Week 260 or End of Study'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Geographic Atrophy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://sanofi.trialsummaries.com/Study/StudyDetails?id=26880&tenant=MT_SNY_9011', 'label': 'DFI18231 Plain Language Results Summary'}]}, 'descriptionModule': {'briefSummary': 'This is a sequential Phase 1/2, two-part, multicenter study on safety, tolerability, and efficacy of one-time intravitreal SAR446597 for the treatment of participants with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD).\n\nThe core phase duration will be approximately 2 years for each participant. An Extended Follow-Up (EFU) phase of 3 years follows the core phase.\n\nThe treatment is a one-time intravitreal injection of SAR446597 (or sham as applicable in Part II).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 60 years old or above\n* Participants with diagnosis of GA secondary to age-related macular degeneration (AMD)\n* Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for dose escalation (Part I) between 20/40 and 20/320 and for expansion (Part II) equal or better than 20/200\n* Study eye with GA lesion measuring between 2.5 and 17.5 mm2 for dose escalation (Part I) and between 2.5 and 14.0 mm2 for expansion (Part II). For multifocal disease, study eye with at least one single lesion of more than 1.25mm2 for both Part I and Part II\n\nExclusion Criteria:\n\n* GA in the study eye caused by a disease different than AMD\n* Presence of neovascularization or a history of treatment with an anti vascular endothelial growth factor agent in the study eye\n* Any condition or treatment (ocular or systemic) or medical or surgical history in the study eye that may prevent visual acuity improvement or interfere with ocular safety or efficacy assessments\n* Current or history of systemic complement targeting treatment in the past 12 months\n* Use of ocular corticosteroids for 4 months (for ocular or periocular injections), 6 months (for intraocular implants) or 3 years (for long lasting intraocular implants) prior to screening in the study eye\n* History of macular laser photocoagulation treatment, photodynamic- or thermotherapy or photo biomodulation in the study eye\n* History of active ocular infection in the study eye in 6 months prior to screening\n* Presence of active ocular or periocular infections\n* Active uncontrolled glaucoma in the study eye\n* History of uveitis or scleritis in either eye\n* Previous gene therapy in either eye\n* Any significant poorly controlled illness that would preclude study compliance and follow up'}, 'identificationModule': {'nctId': 'NCT07215234', 'briefTitle': 'A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Phase 1/2, Study to Evaluate the Safety, Tolerability, and Efficacy of One-time Intravitreal Dose of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration', 'orgStudyIdInfo': {'id': 'DFI18231'}, 'secondaryIdInfos': [{'id': '2025-524508-31', 'type': 'REGISTRY', 'domain': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part I - SAR446597 open-label (OL)', 'description': 'Participants will receive SAR at a dose specified for each cohort. Multiple dose levels of SAR446597 will be evaluated in successive cohorts of participants.', 'interventionNames': ['Drug: SAR446597']}, {'type': 'EXPERIMENTAL', 'label': 'Part II - SAR446597 Dose A', 'description': 'Participants will receive SAR at a dose specified for each arm.', 'interventionNames': ['Drug: SAR446597']}, {'type': 'EXPERIMENTAL', 'label': 'Part II - SAR446597 Dose B', 'description': 'Participants will receive SAR at a dose specified for each arm.', 'interventionNames': ['Drug: SAR446597']}, {'type': 'SHAM_COMPARATOR', 'label': 'Part II - Sham control', 'description': 'Participants will receive Sham at a dose specified for each arm.', 'interventionNames': ['Drug: Sham Comparator']}], 'interventions': [{'name': 'SAR446597', 'type': 'DRUG', 'description': 'Intravitreal injection', 'armGroupLabels': ['Part I - SAR446597 open-label (OL)', 'Part II - SAR446597 Dose A', 'Part II - SAR446597 Dose B']}, {'name': 'Sham Comparator', 'type': 'DRUG', 'description': 'Sham periocular injection', 'armGroupLabels': ['Part II - Sham control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Associated Retina Consultants - Peoria - DocTrials - PPDS- Site Number : 8400011', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '85255', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Macula Institute of Arizona- Site Number : 8400028', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '32607', 'city': 'Gainesville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Vitreo Retinal Associates - Gainesville- Site Number : 8400004', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '60439', 'city': 'Lemont', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University Retina - Lemont- Site Number : 8400005', 'geoPoint': {'lat': 41.67364, 'lon': -88.00173}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Oregon Retina- Site Number : 8400017', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Retina Foundation of the Southwest- Site Number : 8400001', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Texas Retina Associates - Dallas- Site Number : 8400006', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'centralContacts': [{'name': 'Trial Transparency email recommended (Toll free for US & Canada)', 'role': 'CONTACT', 'email': 'contact-us@sanofi.com', 'phone': '800-633-1610', 'phoneExt': 'option 6'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}