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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

Study 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.Check my eligibility
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.See study design
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

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

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
2,163 Previous Clinical Trials
3,512,453 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for individuals to participate in this experiment?

"According to clinicaltrials.gov, the research team is not currently recruiting participants for this study which first began on December 14th 2012 and was last updated on May 6th 2022. Although this trial has concluded recruitment at present, there are presently 160 other active medical trials in need of patient enrolment."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Investigational Site Number : 250001
Investigational Site Number 840001
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Stargerdt disease clinical trial. To see if I can help other people wit Stargarts. I have supplied my DNA for gene research.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Phase I/II Follow-up Study of SAR422459 in Patients With Stargardt's Macular Degeneration
2012. "Phase I/II Follow-up Study of SAR422459 in Patients With Stargardt's Macular Degeneration". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01736592.
All > Age Related Macular Degeneration > Stargardt Disease
~12 spots leftby Aug 2033
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