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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
Led by Sanofi · Updated on 2025-11-21
66
Participants Needed
18
Research Sites
214 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effects of a one-time intravitreal injection of SAR402663 in adults aged 50 to 90 with neovascular age-related macular degeneration (nAMD). This Phase 1/2 study involves two parts: an initial dose escalation phase to test different dose levels, followed by a dose expansion phase where participants receive one of two selected doses. The study aims to assess how well SAR402663 works and its safety over time. Participants receive a single injection of SAR402663 into one eye on Day 1. In Part I, multiple dose levels will be tested in different groups to find the best doses. In Part II, participants are randomly assigned to receive one of two doses chosen from Part I results. Both participants and researchers will not know which dose is given. After the injection, participants will be regularly assessed for 12 months, then enter an extended follow-up period lasting up to five years to monitor long-term safety and treatment effects. During the study, participants will undergo various eye exams and safety assessments, including vision tests and monitoring for any adverse events. Researchers will measure changes in visual acuity and eye health, track the need for additional anti-VEGF treatments, and observe any side effects from the injection. Laboratory tests and vital signs will also be monitored throughout the first year. The extended follow-up phase will continue safety and durability checks over several years, ensuring thorough observation of participants' responses to the treatment.
CONDITIONS
Brief 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
- Diagnosis of macular neovascularization secondary to age-related macular degeneration
- Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent between 20/32 and 20/400 for dose escalation (Part I) and 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 ocular safety or efficacy assessments
- History of active ocular infection in the study eye within 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants receive a one-time intravitreal injection of SAR402663 at the start of the treatment period.
Multiple follow-up visits over 52 weeks to monitor safety and efficacy
Trial Site Locations
Total: 18 locations
1
Site # 8400011
Phoenix, Arizona, United States, 85020
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2
Site # 8400028
Scottsdale, Arizona, United States, 85281
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3
Site # 8400023
Beverly Hills, California, United States, 90211
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4
Site # 8400004
Gainesville, Florida, United States, 32607
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5
Site # 8400002
St. Petersburg, Florida, United States, 33711
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6
Site # 8400010
Augusta, Georgia, United States, 30909
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7
Site # 8400005
Lemont, Illinois, United States, 60439
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8
Site # 8400003
Hagerstown, Maryland, United States, 21740
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9
Site # 8400009
Boston, Massachusetts, United States, 02114-2517
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10
Site # 8400021
Reno, Nevada, United States, 89502
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11
Site # 8400017
Eugene, Oregon, United States, 97401
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12
Site # 8400016
Ladson, South Carolina, United States, 29414
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13
Site # 8400018
Germantown, Tennessee, United States, 38138
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14
Site # 8400008
Abilene, Texas, United States, 79606
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15
Site # 8400015
Austin, Texas, United States, 78705
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16
Site # 8400007
Austin, Texas, United States, 78750
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17
Site # 8400006
Dallas, Texas, United States, 75231
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18
Site # 8400030
San Antonio, Texas, United States, 78240
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Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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