A Phase 1/2 interventional study of SAR402663 and Diluent in Neovascular Age-related Macular Degeneration, sponsored by Sanofi. Active, not recruiting at 26 sites in 2 countries. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Sanofi · Phase 1/2, Interventional, and Treatment
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:
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.
Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Participants will receive a single dose of SAR402663 on Day 1. Multiple dose levels of SAR402663 will be evaluated in successive cohorts of participants.
Biological: SAR402663 · Drug: Diluent
Participants will receive a single dose of SAR402663 on Day 1.
Biological: SAR402663 · Drug: Diluent
Participants will receive a single dose of SAR402663 on Day 1.
Biological: SAR402663 · Drug: Diluent
Pharmaceutical form:Liquid formulation-Route of administration:Intravitreal injection
Pharmaceutical form:Liquid solution-Route of administration:Intravitreal injection
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
Percentage of participants not requiring supplemental anti- vascular endothelial growth factor (VEGF) therapy
Time frame: Day 1 to Week 52 and Week 8 to Week 52
Annualized injection rates of anti-VEGF therapy
Time frame: Day 1 to Week 52
Change from baseline in BCVA using the ETDRS letter score
Visual function of the study eye was assessed at a distance of 4 meters using the best corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score. BCVA scale range is 0 (worst score) to 100 (best score).
Time frame: Baseline, Week 52
Percentage of participants not losing more than or equal to 15 ETDRS letters from baseline
Time frame: Baseline, Week 52
Change from baseline in central subfield thickness (CST), measured by spectral domain optical coherence tomography (SD-OCT)
Time frame: Baseline, Week 52
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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