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

• Status: Active, not recruiting
• Trial end date: 2034-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

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.