NCT06660667 · Sanofi
A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular Degeneration
What this study is about
This is a Phase 1/Phase 2 conducted at multiple hospitals study to evaluate the safety and effectiveness of a one-time single-eye intravitreal dose of SAR402663 in participants with neovascular age-related macular degeneration.
View original scientific description
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.
Interventions
BIOLOGICAL
SAR402663
Pharmaceutical form:Liquid formulation-Route of administration:Intravitreal injection
DRUG
Diluent
Pharmaceutical form:Liquid solution-Route of administration:Intravitreal injection
Primary outcome measures
Incidence and severity of ocular treatment emergent adverse event (TEAEs)
Time frame: Day 1 to Week 52
Incidence and severity of ocular treatment emergent serious adverse event (TESAEs)
Time frame: Day 1 to Week 52
Incidence and severity of non-ocular TEAEs
Time frame: Day 1 to Week 52
Incidence and severity of non-ocular TESAEs
Time frame: Day 1 to Week 52
Number of participants with any clinically significant changes in laboratory variables
Time frame: Day 1 to Week 52
Number of participants with any clinically significant changes in vital signs
Time frame: Day 1 to Week 52
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Currently receiving anti-VEGF treatment in the study eye
- Demonstrated a response to aflibercept in the pre-treatment period
Exclusion criteria
- 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
- Use of ocular corticosteroids in the 3 months prior to screening
- Previous gene therapy
- Any significant poorly controlled illness that would preclude study compliance and follow up The above i
Where
- Phoenix, Arizona
- Scottsdale, Arizona
- Bakersfield, California
- Beverly Hills, California
- Gainesville, Florida
- St. Petersburg, Florida
- Augusta, Georgia
- Lemont, Illinois
- Hagerstown, Maryland
- Towson, Maryland
- Boston, Massachusetts
- Reno, Nevada
And 10 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 13, 2026 · Source of record for eligibility and locations