Stargardt's Disease Clinical Trial
Official title:
A Phase I/IIA Dose Escalation Safety Study of Subretinally Injected SAR422459, Administered to Patients With Stargardt's Macular Degeneration
Primary Objective: To assess the safety and tolerability of ascending doses of SAR422459 in participants with Stargardt's Macular Degeneration (SMD). Secondary Objective: To evaluate for possible biological activity of SAR422459.
The total duration per participant was up to 52 weeks, which included 4 week screening period and 48 weeks study period. At the end of the study, the participants were invited to enter in an open-label safety study (LTS13588-NCT01736592) for long-term follow-up visits including ophthalmological examinations and recording of adverse events (AEs) for up to 15 years. ;
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Phase I/II Follow-up Study of SAR422459 in Patients With Stargardt's Macular Degeneration
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Phase 1/Phase 2 | |
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