Active — Not RecruitingPhase 2

Phase I/II Follow-up Study of SAR422459 in Patients With Stargardt's Macular Degeneration

United States, France27 participantsStarted 2012-12-14

Plain-language summary

Primary Objective: To evaluate the long-term safety and tolerability of SAR422459 in patients with Stargardt's Macular Degeneration. Secondary Objective: To assess: * Safety * Biological activity

Who can participate

Age range6 Years

SexALL

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Inclusion criteria

✓. Provide signed and dated written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act \[HIPAA\])
✓. Must have been enrolled in protocol TDU13583 (SG1/001/10)
✓. Must have received a subretinal injection of SAR422459
✓. Must have completed protocol TDU13583 to Week 48 or undergone an early discontinuation visit.

What they're measuring

The incidence of Adverse Events

Timeframe: 15 years

Trial details

NCT IDNCT01736592

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2033-08-29

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