Actively Recruiting
A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular Degeneration
Led by Sanofi · Updated on 2025-11-21
66
Participants Needed
18
Research Sites
344 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular Degeneration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 50 and 90 years of age
- Diagnosed with macular neovascularization due to age-related macular degeneration (nAMD)
- Study eye with best corrected visual acuity between 20/32 and 20/400 for dose escalation (Part I) or between 20/25 and 20/200 for dose expansion (Part II)
- Current or previous use of anti-vascular endothelial growth factor (VEGF) treatment in the study eye
- Demonstrated a response to anti-VEGF treatment
You will not qualify if you...
- Any condition in the study eye that may prevent visual acuity improvement or interfere with safety or efficacy assessments
- History of active ocular infection in the study eye within 6 months before 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 prevent study compliance and follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Site # 8400011
Phoenix, Arizona, United States, 85020
Actively Recruiting
2
Site # 8400028
Scottsdale, Arizona, United States, 85281
Actively Recruiting
3
Site # 8400023
Beverly Hills, California, United States, 90211
Actively Recruiting
4
Site # 8400004
Gainesville, Florida, United States, 32607
Actively Recruiting
5
Site # 8400002
St. Petersburg, Florida, United States, 33711
Actively Recruiting
6
Site # 8400010
Augusta, Georgia, United States, 30909
Actively Recruiting
7
Site # 8400005
Lemont, Illinois, United States, 60439
Actively Recruiting
8
Site # 8400003
Hagerstown, Maryland, United States, 21740
Actively Recruiting
9
Site # 8400009
Boston, Massachusetts, United States, 02114-2517
Actively Recruiting
10
Site # 8400021
Reno, Nevada, United States, 89502
Actively Recruiting
11
Site # 8400017
Eugene, Oregon, United States, 97401
Actively Recruiting
12
Site # 8400016
Ladson, South Carolina, United States, 29414
Actively Recruiting
13
Site # 8400018
Germantown, Tennessee, United States, 38138
Actively Recruiting
14
Site # 8400008
Abilene, Texas, United States, 79606
Actively Recruiting
15
Site # 8400015
Austin, Texas, United States, 78705
Actively Recruiting
16
Site # 8400007
Austin, Texas, United States, 78750
Actively Recruiting
17
Site # 8400006
Dallas, Texas, United States, 75231
Actively Recruiting
18
Site # 8400030
San Antonio, Texas, United States, 78240
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here