SAR422459 Follow-Up Study for Stargardt Disease

Recruiting at 3 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Sanofi

Disqualifiers: Not received SAR422459

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

27 Participants Needed

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Research Team

David Wilson, MD

Principal Investigator

Oregon Health and Science University

José-Alain Sahel, MD

Principal Investigator

Centre National d'Ophtalmologie des Quinze-Vingts

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])

Exclusion Criteria

Did not receive SAR422459 as part of the TDU13583 protocol.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Long Term Follow-up

Participants are monitored for long-term safety, tolerability, and biological activity of SAR422459

15 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• SAR422459

Trial Overview 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.

Participant Groups

Group I: Long Term Follow up Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University