Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular Degeneration
Sponsor: Sanofi
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
50 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2024-11-21
Completion Date
2031-06-30
Last Updated
2026-07-16
Healthy Volunteers
No
Interventions
SAR402663
Pharmaceutical form:Liquid formulation-Route of administration:Intravitreal injection
Diluent
Pharmaceutical form:Liquid solution-Route of administration:Intravitreal injection
Locations (26)
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
Investigational Site Number : 8260027
Liverpool, United Kingdom