A Study to Determine the Long-Term Safety, Tolerability and Biological Activity of SAR421869 in Patients With Usher Syndrome Type 1B

Running, not enrolling · Phase 2

Conditions studied: Usher's Syndrome

In brief

Primary Objective: To evaluate the long-term safety and tolerability of SAR421869 in patients with Usher syndrome Type 1B Secondary Objective: To assess long-term safety and biological activity of SAR421869

Key facts

Study ID

NCT02065011

Run by

Sanofi

People needed

9

Starts

2013-09-12

Expected to finish

2031-06-13

Last updated by the study team

2026-01-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provide signed and dated written informed consent (and if appropriate assent) and any locally required authorization eg, Health Insurance Portability and Accountability Act (HIPAA).
• Must have been enrolled in protocol TDU13600. Must have received a subretinal injection of SAR421869

You may not qualify if…

• Did not receive SAR421869 as part of the TDU13600 protocol.

Where it is running

• Oregon Health and Science University Site Number : 840001 — Portland, Oregon, United States
• Investigational Site Number : 250001 — Paris, France

Full record on ClinicalTrials.gov

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