A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
Start Date
10/9/2025
Completion Date
7/22/2032
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).
Eligibility Criteria
Age Range: 60 years to No maximum
Interventions
SAR446597
Sham Comparator
Conditions
Locations
Associated Retina Consultants - Peoria- Site Number : 8400011
Peoria, Arizona 85381
United States
Retina Macula Institute of Arizona- Site Number : 8400028
Scottsdale, Arizona 85255
United States
Vitreo Retinal Associates - Gainesville- Site Number : 8400004
Gainesville, Florida 32607
United States
Retina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002
St. Petersburg, Florida 33711
United States
University Retina - Lemont- Site Number : 8400005
Lemont, Illinois 60439
United States
The Retina Group of Washington - Chevy Chase- Site Number : 8400009
Chevy Chase, Maryland 20815
United States
Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003
Hagerstown, Maryland 21740
United States
Oregon Retina- Site Number : 8400017
Eugene, Oregon 97401
United States
Mid Atlantic Retina - Bethlehem- Site Number : 8400031
Bethlehem, Pennsylvania 18017-9412
United States
Retina Consultants of Austin- Site Number : 8400015
Austin, Texas 78705
United States
Austin Clinical Research - Austin - Anderson Mill Road- Site Number : 8400007
Austin, Texas 78750
United States
Retina Consultants of Texas - Bellaire- Site Number : 8400019
Bellaire, Texas 77401
United States
Retina Foundation of the Southwest- Site Number : 8400001
Dallas, Texas 75231
United States
Texas Retina Associates - Dallas- Site Number : 8400006
Dallas, Texas 75231
United States
Retinal Consultants of Texas - San Antonio- Site Number : 8400012
San Antonio, Texas 78240
United States
Investigational Site Number : 0360003
Sydney, New South Wales 2000
Australia
Investigational Site Number : 0360002
Adelaide, South Australia 5000
Australia
Investigational Site Number : 0360001
East Melbourne, Victoria 3002
Australia