SAR422459 Follow-Up Study for Stargardt Disease

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byDavid Wilson, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Sanofi

No Placebo Group

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for patients who have Stargardt's Macular Degeneration and were previously enrolled in the TDU13583 study. Participants must have completed that study up to Week 48 or reached an early discontinuation point, having received a subretinal injection of SAR422459.

Inclusion Criteria

Must have completed protocol TDU13583 to Week 48 or undergone an early discontinuation visit.

I have received a SAR422459 injection in my eye.

Provide signed and dated written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA])

+1 more

Exclusion Criteria

Did not receive SAR422459 as part of the TDU13583 protocol.

Participant Groups

The follow-up study focuses on the long-term safety and tolerability of SAR422459, which was administered to participants in a prior trial. It also aims to assess any ongoing biological activity of the treatment.

1Treatment groups

Experimental Treatment

Group I: Long Term Follow upExperimental Treatment1 Intervention

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