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

Active Not RecruitingPhase 2

Sponsor: Sanofi

Conditions: Stargardt's Disease

Interventions: Long term follow up in all patients who received SAR422459 in previous study TDU13583

Countries: United States, France

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

Eligibility overview

Sex: ALL

Age: 6 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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. Must have received a subretinal injection of SAR422459
4. Must have completed protocol TDU13583 to Week 48 or undergone an early discontinuation visit.

Exclusion Criteria:

The following would exclude Patients from participation in the study:

1\. Did not receive SAR422459 as part of the TDU13583 protocol.

Locations (2)

Portland, Oregon, United States
Paris, France