Status:
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
Lead Sponsor:
Sanofi
Conditions:
Geographic Atrophy
Eligibility:
All Genders
60+ years
Phase:
PHASE1
PHASE2
Brief 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) seco...
Eligibility Criteria
Inclusion
- 60 years old or above
- Participants with diagnosis of GA secondary to age-related macular degeneration (AMD)
- Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for dose escalation (Part I) between 20/40 and 20/320 and for expansion (Part II) equal or better than 20/200
- Study eye with GA lesion measuring between 2.5 and 17.5 mm2 for dose escalation (Part I) and between 2.5 and 14.0 mm2 for expansion (Part II). For multifocal disease, study eye with at least one single lesion of more than 1.25mm2 for both Part I and Part II
Exclusion
- GA in the study eye caused by a disease different than AMD
- Presence of neovascularization or a history of treatment with an anti vascular endothelial growth factor agent in the study eye
- Any condition or treatment (ocular or systemic) or medical or surgical history in the study eye that may prevent visual acuity improvement or interfere with ocular safety or efficacy assessments
- Current or history of systemic complement targeting treatment in the past 12 months
- Use of ocular corticosteroids for 4 months (for ocular or periocular injections), 6 months (for intraocular implants) or 3 years (for long lasting intraocular implants) prior to screening in the study eye
- History of macular laser photocoagulation treatment, photodynamic- or thermotherapy or photo biomodulation in the study eye
- History of active ocular infection in the study eye in 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 preclude study compliance and follow up
Key Trial Info
Start Date :
October 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 22 2032
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT07215234
Start Date
October 9 2025
End Date
July 22 2032
Last Update
January 6 2026
Active Locations (8)
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1
Associated Retina Consultants - Peoria- Site Number : 8400011
Peoria, Arizona, United States, 85381
2
Retina Macula Institute of Arizona- Site Number : 8400028
Scottsdale, Arizona, United States, 85255
3
Vitreo Retinal Associates - Gainesville- Site Number : 8400004
Gainesville, Florida, United States, 32607
4
University Retina - Lemont- Site Number : 8400005
Lemont, Illinois, United States, 60439