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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 DegenerationUnlock trial analytics

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

Frequently asked questions about SAR402663

What is SAR402663 used for?

SAR402663 is an investigational monoclonal antibody being developed for neovascular age-related macular degeneration, a condition that causes abnormal blood vessel growth and vision loss. It is administered as a one-time treatment in adults with this condition. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does SAR402663 target?

SAR402663 is a monoclonal antibody, but its specific molecular target has not been disclosed in available clinical trial information. The drug is being studied for its safety and efficacy in treating neovascular age-related macular degeneration, a disease characterized by abnormal blood vessel growth in the eye. Further research is needed to clarify its mechanism of action.

Who makes SAR402663?

SAR402663 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for the treatment of neovascular age-related macular degeneration.

What phase is SAR402663 in?

SAR402663 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies for commercial use. The ongoing Phase 1 trial is designed to assess the safety and efficacy of a one-time administration of SAR402663 in adults with neovascular age-related macular degeneration.

What clinical trials is SAR402663 in?

SAR402663 is being evaluated in a Phase 1 clinical trial registered as NCT06660667. This study is a randomized, double-blind, controlled trial involving 66 participants with neovascular age-related macular degeneration. The trial is active but not recruiting participants and is being conducted in the United States and United Kingdom.