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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Sanofi • ClinicalTrials.gov ID: NCT07215234

Registry updated: 2026-10-20
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Description

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).

Interventions

  • SAR446597 (Drug)
    Intravitreal injection
  • Sham Comparator (Drug)
    Sham injection

Eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Conditions

Geographic Atrophy

Locations

  • Associated Retina Consultants - Peoria- Site Number : 8400011 — Peoria, Arizona, United States
  • Retina Macula Institute of Arizona- Site Number : 8400028 — Scottsdale, Arizona, United States
  • Retina-Vitreous Associates Medical Group - Beverly Hills- Site Number : 8400033 — Beverly Hills, California, United States
  • The Retina Partners- Site Number : 8400040 — Encino, California, United States
  • California Retina Consultants - Oxnard - North Ventura Road- Site Number : 8400014 — Oxnard, California, United States
  • Retinal Consultants - Sacramento - Parkcenter Drive- Site Number : 8400054 — Sacramento, California, United States
  • Macula Retina Vitreous Center - Torrance- Site Number : 8400053 — Torrance, California, United States
  • Bay Area Retina Associates - Walnut Creek - Lennon Lane- Site Number : 8400039 — Walnut Creek, California, United States
  • Vitreo Retinal Associates - Gainesville- Site Number : 8400004 — Gainesville, Florida, United States
  • Retina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002 — St. Petersburg, Florida, United States
  • East Florida Eye Institute- Site Number : 8400038 — Stuart, Florida, United States
  • Southeast Retina Center- Site Number : 8400044 — Augusta, Georgia, United States
  • University Retina - Lemont- Site Number : 8400005 — Lemont, Illinois, United States
  • The Retina Group of Washington - Chevy Chase- Site Number : 8400009 — Chevy Chase, Maryland, United States
  • Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003 — Hagerstown, Maryland, United States
  • Retina Specialist- Site Number : 8400055 — Towson, Maryland, United States
  • Sierra Eye Associates- Site Number : 8400021 — Reno, Nevada, United States
  • North Carolina (Nc) Retina Associates - Wake Forest Office- Site Number : 8400059 — Wake Forest, North Carolina, United States
  • Oregon Retina- Site Number : 8400017 — Eugene, Oregon, United States
  • Mid Atlantic Retina - Bethlehem- Site Number : 8400031 — Bethlehem, Pennsylvania, United States
  • Erie Retina Research- Site Number : 8400035 — Erie, Pennsylvania, United States
  • Charleston Neuroscience Institute - Ladson- Site Number : 8400016 — Ladson, South Carolina, United States
  • Charleston Neuroscience Institute - Ladson- Site Number : 8400046 — Ladson, South Carolina, United States
  • Texas Retina Associates - Arlington- Site Number : 8400056 — Arlington, Texas, United States
  • Retina Consultants of Austin- Site Number : 8400015 — Austin, Texas, United States
  • Austin Clinical Research - Austin - Anderson Mill Road- Site Number : 8400007 — Austin, Texas, United States
  • Retina Consultants of Texas - Bellaire- Site Number : 8400019 — Bellaire, Texas, United States
  • Retina Foundation of the Southwest- Site Number : 8400001 — Dallas, Texas, United States
  • Texas Retina Associates - Dallas- Site Number : 8400006 — Dallas, Texas, United States
  • Retinal Consultants of Texas - San Antonio- Site Number : 8400012 — San Antonio, Texas, United States
  • Retina Center of Texas (RCT) - Southlake- Site Number : 8400048 — Southlake, Texas, United States
  • Investigational Site Number : 0360003 — Sydney, New South Wales, Australia
  • Investigational Site Number : 0360002 — Adelaide, South Australia, Australia
  • Investigational Site Number : 0360001 — East Melbourne, Victoria, Australia
  • Investigational Site Number : 8260001 — London, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record