A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular Degeneration (NCT06660667)
A Phase 1/2 Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, and Efficacy of One-time Intravitreal Dose of SAR402663 in Participants With Neovascular Age-related Macular Degeneration
🩺 Plain-English Summary (8th-Grade Level)
This is a Phase 1/Phase 2 multicenter study to evaluate the safety and efficacy of a one-time single-eye intravitreal dose of SAR402663 in participants with neovascular age-related macular degeneration. Participants will be enrolled in one of 2 parts: * In Part I (dose escalation), multiple dose levels of SAR402663 will be evaluated in successive cohorts of participants * In Part II (dose expansion), participants will be randomized to receive one of two dose levels selected based on data from Part I. Participants, investigators and outcomes assessors will be masked to dose. After receiving one-time dose of SAR402663, participants will undergo regular assessments over 12 months. Following this, participants will enter an extended follow-up (EFU) phase for the assessment of safety and durability of clinical activity of SAR402663 through Year 5.
Who can join: Review the eligibility criteria below.
Location: Associated Retina Consultants - Phoenix- Site Number : 8400011 — Phoenix, Arizona
Age range: 50 Years to 90 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (26 Sites)
Showing the first 25 of 26 sites.
- Associated Retina Consultants - Phoenix- Site Number : 8400011 — Phoenix, Arizona
- Retina Macula Institute of Arizona- Site Number : 8400028 — Scottsdale, Arizona
- California Retina Consultants - Bakersfield- Site Number : 8400001 — Bakersfield, California
- Retina-Vitreous Associates Medical Group - Beverly Hills- Site Number : 8400023 — Beverly Hills, California
- Vitreo Retinal Associates - Gainesville- Site Number : 8400004 — Gainesville, Florida
- Retina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002 — St. Petersburg, Florida
- Southeast Retina Center- Site Number : 8400010 — Augusta, Georgia
- University Retina - Lemont- Site Number : 8400005 — Lemont, Illinois
- Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003 — Hagerstown, Maryland
- Retina Specialist- Site Number : 8400020 — Towson, Maryland
- Ophthalmic Consultants of Boston - Boston- Site Number : 8400009 — Boston, Massachusetts
- Sierra Eye Associates- Site Number : 8400021 — Reno, Nevada
- North Carolina (Nc) Retina Associates - Wake Forest Office- Site Number : 8400033 — Wake Forest, North Carolina
- Oregon Retina- Site Number : 8400017 — Eugene, Oregon
- Mid Atlantic Retina- Site Number : 8400032 — Bethlehem, Pennsylvania
- Charleston Neuroscience Institute - Ladson- Site Number : 8400016 — Ladson, South Carolina
- Charles Retina Institution- Site Number : 8400018 — Germantown, Tennessee
- Retina Research Institute of Texas- Site Number : 8400008 — Abilene, Texas
- Austin Research Center for Retina- Site Number : 8400015 — Austin, Texas
- Austin Clinical Research - Austin - Anderson Mill Road- Site Number : 8400007 — Austin, Texas
- Texas Retina Associates - Dallas- Site Number : 8400006 — Dallas, Texas
- Medical Center Ophthalmology Associates- Site Number : 8400030 — San Antonio, Texas
- Retinal Consultants of Texas - San Antonio- Site Number : 8400012 — San Antonio, Texas
- Retina Consultants of Texas - The Woodlands- Site Number : 8400019 — The Woodlands, Texas
- Investigational Site Number : 8260024 — London, Westminster
💰 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 § 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.
More studies in Neovascular Age-related Macular Degeneration
- A Phase 3b, Single-Arm Study of Aflibercept 8 mg Dosed Every 4 Weeks in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME) — Arcadia, California
- Effect of AIV007 by Periocular Administration in Subjects with Macular Edema Secondary to Neovascular Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) — Beverly Hills, California
- Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration — Gilbert, Arizona
- Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD — Glendale, California
- Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA] — Phoenix, Arizona
Explore by condition: All Neovascular Age-related Macular Degeneration clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.