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SAR422459 Follow-Up Study for Stargardt Disease

Phase 1 & 2
Waitlist Available
Led By David Wilson, MD
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have received a subretinal injection of SAR422459
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will evaluate the long-term safety and tolerability of SAR422459 in patients with Stargardt's Macular Degeneration. Secondary objectives include assessing safety and biological activity.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this is a follow-up, side effects are monitored over the long term but may include issues related to eye surgery such as discomfort, inflammation, infection risk, vision changes, or other potential complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have received a SAR422459 injection in my eye.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The incidence of Adverse Events
Secondary study objectives
Clinically important changes in ocular safety assessments
Delay in retinal degeneration

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,209 Previous Clinical Trials
4,039,740 Total Patients Enrolled
1 Trials studying Stargardt Disease
27 Patients Enrolled for Stargardt Disease
David Wilson, MDPrincipal InvestigatorOregon Health and Science University
3 Previous Clinical Trials
196 Total Patients Enrolled
José-Alain Sahel, MDPrincipal InvestigatorCentre National d'Ophtalmologie des Quinze-Vingts
1 Previous Clinical Trials
1,500 Total Patients Enrolled

Media Library

Long Term Follow up Clinical Trial Eligibility Overview. Trial Name: NCT01736592 — Phase 1 & 2
Stargardt Disease Research Study Groups: Long Term Follow up
Stargardt Disease Clinical Trial 2023: Long Term Follow up Highlights & Side Effects. Trial Name: NCT01736592 — Phase 1 & 2
Long Term Follow up 2023 Treatment Timeline for Medical Study. Trial Name: NCT01736592 — Phase 1 & 2
~11 spots leftby Aug 2033
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