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NCT07215234 · ClinicalTrials.gov registry record · Phase 1
A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
A Phase 1 study of Geographic Atrophy, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 104
- Enrollment target
- 13
- Study locations
NCT07215234 is a Phase 1 study of Geographic Atrophy that is actively recruiting participants, run by Sanofi. The registered enrollment target is 104 participants, below the 218-participant average among 27 other Geographic Atrophy trials with a reported enrollment target (52% lower). The trial reports 13 study locations across 7 states.
The verdict
NCT07215234, a Phase 1 study of Geographic Atrophy, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 104 participants
- Enrollment target
- 13
- Study locations
Study Summary
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). The core phase duration will be approximately 2 years for each participant. An Extended Follow-Up (EFU) phase of 3 years follows the core phase. The treatment is a one-time intravitreal injection of SAR446597 (or sham as applicable in Part II).
Conditions Studied
Interventions
- DRUG SAR446597
- DRUG Sham Comparator
Study Locations (13)
Texas
- Austin Clinical Research - Austin - Anderson Mill Road- Site Number : 8400007 - Austin
- Retina Foundation of the Southwest- Site Number : 8400001 - Dallas
- Texas Retina Associates - Dallas- Site Number : 8400006 - Dallas
- Retinal Consultants of Texas - San Antonio- Site Number : 8400012 - San Antonio
Arizona
- Associated Retina Consultants - Peoria- Site Number : 8400011 - Peoria
- Retina Macula Institute of Arizona- Site Number : 8400028 - Scottsdale
Florida
- Vitreo Retinal Associates - Gainesville- Site Number : 8400004 - Gainesville
- Retina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002 - St. Petersburg
Maryland
- The Retina Group of Washington - Chevy Chase- Site Number : 8400009 - Chevy Chase
- Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003 - Hagerstown
Illinois
- University Retina - Lemont- Site Number : 8400005 - Lemont
Oregon
- Oregon Retina- Site Number : 8400017 - Eugene
Pennsylvania
- Mid Atlantic Retina- Site Number : 8400031 - Bethlehem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2025-10-09 |
| Est. Completion | 2032-07-22 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07215234
The ClinicalTrials.gov registry entry for NCT07215234 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 218-participant average among 27 other Geographic Atrophy trials with a reported enrollment target (52% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Geographic Atrophy appearing as the primary indexed condition, and to 2 interventions - of which SAR446597 is the first listed.
NCT07215234 reports 13 study locations spanning 7 distinct geographic areas - top geographies include Texas, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT07215234 about?
NCT07215234 is a clinical study titled "A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration". 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). The core phase duration will be approximately 2 ye...
What is the current status of trial NCT07215234?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 104 participants. The study started on 2025-10-09. Estimated completion is 2032-07-22.
What conditions does trial NCT07215234 study?
This clinical trial studies the following conditions: Geographic Atrophy.
What interventions are being tested in trial NCT07215234?
The interventions under investigation include: SAR446597 (DRUG), Sham Comparator (DRUG).
Who is sponsoring clinical trial NCT07215234?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07215234 being conducted?
This trial has 13 study locations across Arizona, Florida, Illinois, Maryland, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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