A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

Part of paid clinical trials in Peoria, Arizona.

Sponsor
Sanofi
Study ID
NCT07215234
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SAR446597 — DRUG
    Intravitreal injection
  • Sham Comparator — DRUG
    Sham injection

Study Details

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).

Key Dates

Start date
Oct 9, 2025
Status verified
Apr 2026
Primary completion
Oct 13, 2027
Completion
Jul 22, 2032

Study Design

Enrollment
104 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part I - SAR446597 open-label (OL)
    Participants will receive SAR at a dose specified for each cohort. Multiple dose levels of SAR446597 will be evaluated in successive cohorts of participants.
  • Experimental: Part II - SAR446597 Dose A
    Participants will receive SAR at a dose specified for each arm.
  • Experimental: Part II - SAR446597 Dose B
    Participants will receive SAR at a dose specified for each arm.
  • Sham Comparator: Part II - Sham control
    Participants will receive Sham at a dose specified for each arm.

Primary Outcome Measure

Incidence and severity of ocular and non-ocular treatment-emergent adverse events (TEAEs) [ Time Frame: Day 1 to Week 104 ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

Locations (14)

FacilityCityStateZIPSite coordinators
Associated Retina Consultants - Peoria- Site Number : 8400011PeoriaArizona85381-
Retina Macula Institute of Arizona- Site Number : 8400028ScottsdaleArizona85255-
Vitreo Retinal Associates - Gainesville- Site Number : 8400004GainesvilleFlorida32607-
Retina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002St. PetersburgFlorida33711-
University Retina - Lemont- Site Number : 8400005LemontIllinois60439-
The Retina Group of Washington - Chevy Chase- Site Number : 8400009Chevy ChaseMaryland20815-
Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003HagerstownMaryland21740-
Oregon Retina- Site Number : 8400017EugeneOregon97401-
Mid Atlantic Retina - Bethlehem- Site Number : 8400031BethlehemPennsylvania18017-9412-
Austin Clinical Research - Austin - Anderson Mill Road- Site Number : 8400007AustinTexas78750-
Retina Consultants of Texas - Bellaire- Site Number : 8400019BellaireTexas77401-
Retina Foundation of the Southwest- Site Number : 8400001DallasTexas75231-
Texas Retina Associates - Dallas- Site Number : 8400006DallasTexas75231-
Retinal Consultants of Texas - San Antonio- Site Number : 8400012San AntonioTexas78240-

Find similar trials in Peoria, AZ

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Associated Retina Consultants - Peoria· Peoria, AZRetina Macula Institute of Arizona· Scottsdale, AZVitreo Retinal Associates - Gainesville· Gainesville, FLRetina Vitreous Associates of Florida - St. Petersburg· St. Petersburg, FLUniversity Retina - Lemont· Lemont, ILThe Retina Group of Washington - Chevy Chase· Chevy Chase, MD

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