๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-06-30

A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration (NCT07215234)

A Phase 1/2, Study to Evaluate the Safety, Tolerability, and Efficacy of One-time Intravitreal Dose of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

๐ŸŸข Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Sanofi

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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).

Who can join: Review the eligibility criteria below.

Location: Associated Retina Consultants - Peoria- Site Number : 8400011 โ€” Peoria, Arizona

Age range: 60 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (18 Sites)

  • Associated Retina Consultants - Peoria- Site Number : 8400011 โ€” Peoria, Arizona
  • Retina Macula Institute of Arizona- Site Number : 8400028 โ€” Scottsdale, Arizona
  • Vitreo Retinal Associates - Gainesville- Site Number : 8400004 โ€” Gainesville, Florida
  • Retina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002 โ€” St. Petersburg, Florida
  • University Retina - Lemont- Site Number : 8400005 โ€” Lemont, Illinois
  • The Retina Group of Washington - Chevy Chase- Site Number : 8400009 โ€” Chevy Chase, Maryland
  • Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003 โ€” Hagerstown, Maryland
  • Oregon Retina- Site Number : 8400017 โ€” Eugene, Oregon
  • Mid Atlantic Retina - Bethlehem- Site Number : 8400031 โ€” Bethlehem, Pennsylvania
  • Retina Consultants of Austin- Site Number : 8400015 โ€” Austin, Texas
  • Austin Clinical Research - Austin - Anderson Mill Road- Site Number : 8400007 โ€” Austin, Texas
  • Retina Consultants of Texas - Bellaire- Site Number : 8400019 โ€” Bellaire, Texas
  • Retina Foundation of the Southwest- Site Number : 8400001 โ€” Dallas, Texas
  • Texas Retina Associates - Dallas- Site Number : 8400006 โ€” Dallas, Texas
  • Retinal Consultants of Texas - San Antonio- Site Number : 8400012 โ€” San Antonio, Texas
  • Investigational Site Number : 0360003 โ€” Sydney, New South Wales
  • Investigational Site Number : 0360002 โ€” Adelaide, South Australia
  • Investigational Site Number : 0360001 โ€” East Melbourne, Victoria

๐Ÿ“ž Contact the Study Coordinator

Phone: (800) 633-1610

Email: contact-us@sanofi.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—