A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular Degeneration

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Neovascular Age-related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT06660667

Run by

Sanofi

People needed

66

Starts

2024-11-21

Expected to finish

2031-06-30

Last updated by the study team

2026-07-16

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Between 50 and 90 years of age
• Participants with diagnosis of macular neovascularization secondary to age-related macular degeneration (nAMD)
• Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for dose escalation (Part I) between 20/32 and 20/400 and for expansion (Part II) between 20/25 and 20/200
• Current or previous use of anti-vascular endothelial growth factor (VEGF) treatment in the study eye
• Demonstrated a response to anti-VEGF treatment

You may not qualify if…

• Any condition in the study eye that may prevent visual acuity improvement or interfere with ocular safety or efficacy assessments
• History of active ocular infection in the study eye in 6 months prior to screening
• Active uncontrolled glaucoma in the study eye
• History of uveitis in either eye
• Current use of ocular corticosteroids in the study eye
• Previous gene therapy
• 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 potential participation in a clinical trial.

Where it is running

• Associated Retina Consultants - Phoenix- Site Number : 8400011 — Phoenix, Arizona, United States
• Retina Macula Institute of Arizona- Site Number : 8400028 — Scottsdale, Arizona, United States
• California Retina Consultants - Bakersfield- Site Number : 8400001 — Bakersfield, California, United States
• Retina-Vitreous Associates Medical Group - Beverly Hills- Site Number : 8400023 — Beverly Hills, 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
• Southeast Retina Center- Site Number : 8400010 — Augusta, Georgia, United States
• University Retina - Lemont- Site Number : 8400005 — Lemont, Illinois, United States
• Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003 — Hagerstown, Maryland, United States
• Retina Specialist- Site Number : 8400020 — Towson, Maryland, United States
• Ophthalmic Consultants of Boston - Boston- Site Number : 8400009 — Boston, Massachusetts, United States
• Sierra Eye Associates- Site Number : 8400021 — Reno, Nevada, United States
• North Carolina (Nc) Retina Associates - Wake Forest Office- Site Number : 8400033 — Wake Forest, North Carolina, United States
• Oregon Retina- Site Number : 8400017 — Eugene, Oregon, United States
• Mid Atlantic Retina- Site Number : 8400032 — Bethlehem, Pennsylvania, United States
• Charleston Neuroscience Institute - Ladson- Site Number : 8400016 — Ladson, South Carolina, United States
• Charles Retina Institution- Site Number : 8400018 — Germantown, Tennessee, United States
• Retina Research Institute of Texas- Site Number : 8400008 — Abilene, Texas, United States
• Austin Research Center for Retina- Site Number : 8400015 — Austin, Texas, United States
• Austin Clinical Research - Austin - Anderson Mill Road- Site Number : 8400007 — Austin, Texas, United States
• Texas Retina Associates - Dallas- Site Number : 8400006 — Dallas, Texas, United States
• Medical Center Ophthalmology Associates- Site Number : 8400030 — San Antonio, Texas, United States
• Retinal Consultants of Texas - San Antonio- Site Number : 8400012 — San Antonio, Texas, United States
• Retina Consultants of Texas - The Woodlands- Site Number : 8400019 — The Woodlands, Texas, United States
• Investigational Site Number : 8260024 — London, Westminster, United Kingdom

Full record on ClinicalTrials.gov

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