Overview

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

Status:
Active, not recruiting
Trial end date:
2032-06-01
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Criteria
Inclusion criteria :

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

Exclusion criteria:

Did not receive SAR421869 as part of the TDU13600 protocol.