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SAR446597

Phase 1

Geographic Atrophy | Small molecule | Ophthalmology |Sanofi|Last Updated: Jul 1, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindSHAM_CONTROLLED
Total Trials1
Total Enrollment104
FDA Designations
FAST_TRACK
Clinical trial landscape

SAR446597 · 1 trial · 1 indication

Phase 1 1
NCT07215234A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular DegenerationGeographic Atrophy
RECRUITING104 Analytics
PHASE1RECRUITING
A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
Geographic Atrophy
NCT07215234104
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Study Endpoints
Primary Endpoints
Incidence and severity of ocular and non-ocular treatment-emergent adverse events (TEAEs)
Day 1 to Week 104
Incidence and severity of ocular and non-ocular treatment-emergent serious adverse events (TESAEs)
Day 1 to Week 104
Secondary Endpoints
Change in square root-transformed (mm) and untransformed area (mm2) of GA
Baseline, Week 52, Week 104
Change in best-corrected visual acuity (BCVA) from baseline to Week 52 and Week 104 following SAR446597 administration measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
Baseline, Week 52, Week 104
Percentage of participants without loss of BCVA of ≥15 ETDRS letters from baseline in the study eye
Baseline, Week 52, Week 104
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part I - SAR446597 open-label (OL)EXPERIMENTALParticipants will receive SAR at a dose specified for each cohort. Multiple dose levels of SAR446597 will be evaluated in successive cohorts of participants.
Part II - SAR446597 Dose AEXPERIMENTALParticipants will receive SAR at a dose specified for each arm.
Part II - SAR446597 Dose BEXPERIMENTALParticipants will receive SAR at a dose specified for each arm.
Part II - Sham controlSHAM_COMPARATORParticipants will receive Sham at a dose specified for each arm.
Interventions
NameTypeDescription
SAR446597DRUGIntravitreal injection
Sham ComparatorDRUGSham injection
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Eligibility Criteria
Age Range60 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * 60 years old or above * Participants with diagnosis of GA secondary to age-related macular degeneration (AMD) * Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for dose escalation (Part I) between 20/40 and 20/320 and for expansion (Part II) equal o...

Countries:United StatesAustralia
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Competitive Landscape -Geographic Atrophy 9 trials
CompanyTickerTrialsLead PhaseDrugs
Regeneron Pharmaceuticals, Inc.REGN2PHASE3Pozelimab, Cemdisiran
Annexon, Inc.ANNX1PHASE3Vonaprument
Belite Bio, Inc. ADRBLTE1PHASE3Tinlarebant
Johnson & JohnsonJNJ1PHASE2JNJ-81201887
AbbVie, Inc.ABBV1PHASE1ABBV-6628, SYFOVRE
Sanofi SA Sponsored ADRSNY1PHASE1SAR446597, Sham Comparator
Ocugen IncOCGN1PHASE1OCU410
Apellis Pharmaceuticals, Inc.APLS1 - Pegcetacoplan
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Recent Changes (Last 90 Days)
LOWJul 2, 2026NCT07215234lastUpdatePostDate: changed
LOWJul 2, 2026NCT07215234lastUpdatePostDate: changed
LOWJul 2, 2026NCT07215234lastUpdatePostDate: changed
LOWJul 2, 2026NCT07215234lastUpdatePostDate: changed
LOWMay 26, 2026NCT07215234primaryCompletionDate: changed
LOWMay 24, 2026NCT07215234studyFirstPostDate: changed