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Monoclonal Antibodies

SAR421869 for Usher Syndrome

Phase 2
Waitlist Available
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 SAR421869
Must have received a subretinal injection of SAR421869
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights

Study Summary

This trial will evaluate the safety and tolerability of SAR421869 in people with Usher syndrome Type 1B.

Who is the study for?
This trial is for patients with Usher Syndrome Type 1B who previously enrolled in the TDU13600 protocol and received a subretinal injection of SAR421869. Participants must have given written consent. Those who did not receive SAR421869 as part of the earlier TDU13600 study cannot join.Check my eligibility
What is being tested?
The study focuses on long-term safety, tolerability, and biological activity of SAR421869 in individuals with Usher Syndrome Type 1B. It involves regular blood draws to monitor these aspects over an extended period.See study design
What are the potential side effects?
While specific side effects are not listed, this trial aims to assess any long-term adverse reactions or issues related to the tolerability of SAR421869 following its subretinal administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have received a specific eye treatment injection (SAR421869).
Select...
I have received a SAR421869 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 of patients who received SAR421869 in a previous study TDU13600

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,158 Previous Clinical Trials
3,514,339 Total Patients Enrolled
Clinical Sciences & Operations, MDStudy DirectorSanofi
4 Previous Clinical Trials
231 Total Patients Enrolled

Media Library

SAR421869 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02065011 — Phase 2
Usher Syndrome Research Study Groups: Long-term follow up
Usher Syndrome Clinical Trial 2023: SAR421869 Highlights & Side Effects. Trial Name: NCT02065011 — Phase 2
SAR421869 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02065011 — Phase 2

Frequently Asked Questions

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

Are researchers recruiting participants for this trial at present?

"Unfortunately, this study is no longer recruiting patients as of the last update on May 9th, 2022. However, there are 1453 other trials that are still looking for participants."

Answered by AI

Who else is applying?

What site did they apply to?
Investigational Site Number 250001
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

just have a hope.
PatientReceived no prior treatments
~4 spots leftby Jun 2031