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SAR422459

Phase 2

Stargardt's Disease | Small molecule | Ophthalmology |Sanofi|Last Updated: Aug 26, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

SAR422459 · 1 trial · 1 indication

Phase 2 1
NCT01736592Phase I/II Follow-up Study of SAR422459 in Patients With Stargardt's Macular DegenerationStargardt's Disease
ACTIVE NOT_RECRUITING27 Analytics
PHASE2ACTIVE NOT_RECRUITING
Phase I/II Follow-up Study of SAR422459 in Patients With Stargardt's Macular Degeneration
Stargardt's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

The incidence of Adverse Events
15 years

The number and percentage of patients with treatment emergent adverse events

Secondary Endpoints

Clinically important changes in ocular safety assessments
baseline to 15 years
Delay in retinal degeneration
baseline to 15 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
Long Term Follow upOTHERLong term follow up in all patients who received SAR422459 in previous study TDU13583

Interventions

NameTypeDescription
Long term follow up in all patients who received SAR422459 in previous study TDU13583DRUGBlood draw for the laboratory assessment
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Eligibility Criteria

Age Range6 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: Patients must meet ALL of the following criteria: 1. Provide signed and dated written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act \[HIPAA\]) 2. Must have been enrolled in protocol TDU13583 (SG1/001/10) 3. Mu...

Countries:United StatesFrance
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Recent Changes (Last 90 Days)

LOWAug 26, 2026NCT01736592lastUpdatePostDate: changed
LOWAug 26, 2026NCT01736592lastUpdatePostDate: changed