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SAR402663

Phase 1

Neovascular Age-related Macular Degeneration | Monoclonal antibody | Ophthalmology |Sanofi|Last Updated: Jul 16, 2026

Success Probability
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment66
FDA Designations
No designations recorded
Clinical trial landscape

SAR402663 · 1 trial · 1 indication

Phase 1 1
NCT06660667A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular DegenerationNeovascular Age-related Macular Degeneration
ACTIVE NOT_RECRUITING66 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular Degeneration
Neovascular Age-related Macular Degeneration
NCT0666066766
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Study Endpoints
Primary Endpoints
Incidence and severity of ocular treatment emergent adverse event (TEAEs)
Day 1 to Week 52
Incidence and severity of ocular treatment emergent serious adverse event (TESAEs)
Day 1 to Week 52
Incidence and severity of non-ocular TEAEs
Day 1 to Week 52
Incidence and severity of non-ocular TESAEs
Day 1 to Week 52
Number of participants with any clinically significant changes in laboratory variables
Day 1 to Week 52
Number of participants with any clinically significant changes in vital signs
Day 1 to Week 52
Secondary Endpoints
Percentage of participants not requiring supplemental anti- vascular endothelial growth factor (VEGF) therapy
Day 1 to Week 52 and Week 8 to Week 52
Annualized injection rates of anti-VEGF therapy
Day 1 to Week 52
Change from baseline in BCVA using the ETDRS letter score
Baseline, Week 52
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part I - SAR402663 open-label (OL)EXPERIMENTALParticipants will receive a single dose of SAR402663 on Day 1. Multiple dose levels of SAR402663 will be evaluated in successive cohorts of participants.
Part II - SAR402663 Dose AEXPERIMENTALParticipants will receive a single dose of SAR402663 on Day 1.
Part II - SAR402663 Dose BEXPERIMENTALParticipants will receive a single dose of SAR402663 on Day 1.
Interventions
NameTypeDescription
SAR402663BIOLOGICALPharmaceutical form:Liquid formulation-Route of administration:Intravitreal injection
DiluentDRUGPharmaceutical form:Liquid solution-Route of administration:Intravitreal injection
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Eligibility Criteria
Age Range50 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites26

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 a...

Countries:United StatesUnited Kingdom
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Recent Changes (Last 90 Days)
MEDIUMJul 17, 2026NCT06660667Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJul 17, 2026NCT06660667Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJul 17, 2026NCT06660667Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJul 13, 2026NCT06660667lastUpdatePostDate: changed
LOWJul 13, 2026NCT06660667lastUpdatePostDate: changed
LOWMay 26, 2026NCT06660667primaryCompletionDate: changed
LOWMay 24, 2026NCT06660667studyFirstPostDate: changed