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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: Sanofi
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).
Official title: 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
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
104
Start Date
2025-10-09
Completion Date
2032-07-22
Last Updated
2026-03-23
Healthy Volunteers
No
Conditions
Interventions
SAR446597
Intravitreal injection
Sham Comparator
Sham injection
Locations (13)
Associated Retina Consultants - Peoria- Site Number : 8400011
Peoria, Arizona, United States
Retina Macula Institute of Arizona- Site Number : 8400028
Scottsdale, Arizona, United States
Vitreo Retinal Associates - Gainesville- Site Number : 8400004
Gainesville, Florida, United States
Retina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002
St. Petersburg, Florida, United States
University Retina - Lemont- Site Number : 8400005
Lemont, Illinois, United States
The Retina Group of Washington - Chevy Chase- Site Number : 8400009
Chevy Chase, Maryland, United States
Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003
Hagerstown, Maryland, United States
Oregon Retina- Site Number : 8400017
Eugene, Oregon, United States
Mid Atlantic Retina- Site Number : 8400031
Bethlehem, Pennsylvania, United States
Austin Clinical Research - Austin - Anderson Mill Road- Site Number : 8400007
Austin, Texas, United States
Retina Foundation of the Southwest- Site Number : 8400001
Dallas, Texas, United States
Texas Retina Associates - Dallas- Site Number : 8400006
Dallas, Texas, United States
Retinal Consultants of Texas - San Antonio- Site Number : 8400012
San Antonio, Texas, United States