Actively Recruiting
A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
Led by Sanofi · Updated on 2026-04-21
104
Participants Needed
17
Research Sites
354 weeks
Total Duration
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AI-Summary
What this Trial Is About
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
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 60 years old or above
- Diagnosis of Geographic Atrophy secondary to Age-related Macular Degeneration
- Study eye with best corrected visual acuity (BCVA) between 20/40 and 20/320 for Part I and equal or better than 20/200 for Part II
- Study eye with GA lesion size between 2.5 and 17.5 mm2 for Part I and between 2.5 and 14.0 mm2 for Part II
- For multifocal disease, study eye must have at least one lesion larger than 1.25 mm2
You will not qualify if you...
- GA in the study eye caused by diseases other than AMD
- Presence of neovascularization or history of anti-vascular endothelial growth factor treatment in the study eye
- Any ocular or systemic condition or treatment that may prevent visual acuity improvement or interfere with safety or efficacy assessments
- Current or past 12 months systemic complement targeting treatment
- Use of ocular corticosteroids within specified times before screening
- History of macular laser photocoagulation, photodynamic, thermotherapy, or photobiomodulation in the study eye
- Active ocular infection in the study eye within 6 months before screening
- Presence of active ocular or periocular infections
- Active uncontrolled glaucoma in the study eye
- History of uveitis or scleritis in either eye
- Previous gene therapy in either eye
- Significant poorly controlled illness that would prevent study compliance and follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Associated Retina Consultants - Peoria- Site Number : 8400011
Peoria, Arizona, United States, 85381
Actively Recruiting
2
Retina Macula Institute of Arizona- Site Number : 8400028
Scottsdale, Arizona, United States, 85255
Actively Recruiting
3
Vitreo Retinal Associates - Gainesville- Site Number : 8400004
Gainesville, Florida, United States, 32607
Actively Recruiting
4
Retina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002
St. Petersburg, Florida, United States, 33711
Actively Recruiting
5
University Retina - Lemont- Site Number : 8400005
Lemont, Illinois, United States, 60439
Actively Recruiting
6
The Retina Group of Washington - Chevy Chase- Site Number : 8400009
Chevy Chase, Maryland, United States, 20815
Actively Recruiting
7
Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003
Hagerstown, Maryland, United States, 21740
Actively Recruiting
8
Oregon Retina- Site Number : 8400017
Eugene, Oregon, United States, 97401
Actively Recruiting
9
Mid Atlantic Retina - Bethlehem- Site Number : 8400031
Bethlehem, Pennsylvania, United States, 18017-9412
Actively Recruiting
10
Austin Clinical Research - Austin - Anderson Mill Road- Site Number : 8400007
Austin, Texas, United States, 78750
Actively Recruiting
11
Retina Consultants of Texas - Bellaire- Site Number : 8400019
Bellaire, Texas, United States, 77401
Actively Recruiting
12
Retina Foundation of the Southwest- Site Number : 8400001
Dallas, Texas, United States, 75231
Actively Recruiting
13
Texas Retina Associates - Dallas- Site Number : 8400006
Dallas, Texas, United States, 75231
Actively Recruiting
14
Retinal Consultants of Texas - San Antonio- Site Number : 8400012
San Antonio, Texas, United States, 78240
Actively Recruiting
15
Investigational Site Number : 0360003
Sydney, New South Wales, Australia, 2000
Actively Recruiting
16
Investigational Site Number : 0360002
Adelaide, South Australia, Australia, 5000
Actively Recruiting
17
Investigational Site Number : 0360001
East Melbourne, Victoria, Australia, 3002
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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