Actively Recruiting
Safety, Tolerability, and Efficacy Study of 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
249 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of a one-time intravitreal injection of SAR446597 in participants with Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD). This is a Phase 1/2, two-part, multicenter study that aims to understand how this treatment affects participants with this condition over time. Participants will receive a one-time injection of SAR446597 or a sham injection depending on the study part and group assignment. Multiple dose levels of SAR446597 will be tested in successive cohorts during Part I, followed by dose-specific groups and a sham control group in Part II. The core study phase lasts about 2 years, after which participants enter an Extended Follow-Up phase for an additional 3 years to monitor long-term outcomes. During the study, participants will undergo regular assessments including eye exams, visual acuity tests, and monitoring for any adverse events related to the treatment. Researchers will measure changes in the size of GA lesions and visual acuity at several time points up to 2 years, with safety follow-up extending to 5 years. This approach helps evaluate treatment effects and long-term safety in those receiving SAR446597 or sham injections.
CONDITIONS
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
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 (AMD)
- Study eye with best corrected visual acuity (BCVA) between 20/40 and 20/320 for dose escalation (Part I)
- Study eye with BCVA equal or better than 20/200 for expansion (Part II)
- Study eye with GA lesion size between 2.5 and 17.5 mm2 for dose escalation (Part I)
- Study eye with GA lesion size between 2.5 and 14.0 mm2 for expansion (Part II)
- For multifocal disease, study eye must have at least one single 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 condition or treatment that may prevent vision improvement or interfere with safety or efficacy assessments in the study eye
- Current or past 12 months systemic complement targeting treatment
- Use of ocular corticosteroids within specified timeframes before screening in the study eye
- History of macular laser photocoagulation, photodynamic therapy, thermotherapy, or photobiomodulation in the study eye
- Active ocular infection in the study eye within 6 months prior to 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
- Any significant poorly controlled illness that would prevent study compliance or follow-up
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 1
Participants receive a one-time intravitreal injection of SAR446597 or a sham injection as part of the study treatment.
1 treatment visit (in-person)
Duration - Up to 5 years
Participants are monitored for safety and efficacy following the injection, with assessments continuing up to Week 104 and long-term safety monitoring up to Week 260 or end of study.
Regular visits during the first 104 weeks; additional safety visits up to Week 260 or end of study
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)
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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