2024-513500-34-00RecruitingPhase 2
An open-label study to determine the long-term safety, tolerability and biological activity of SAR421869 in patients with Usher syndrome Type 1B
Sanofi-Aventis Recherche & Developpement1 site in 1 country4 target enrollmentStarted: September 12, 2024Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- The incidence of adverse events
Study Overview
Brief Summary
To evaluate the long-term safety and tolerability of SAR421869 in patients with Usher syndrome Type 1B
Eligibility Criteria
- Ages
- 18 years to 64 years (18-64 Years)
- Accepts Healthy Volunteers
- Yes
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 TDU
- •Must have received a subretinal injection of SAR421869
Exclusion Criteria
- •Did not receive SAR421869 as part of the TDU13600 protocol.
Outcomes
Primary Outcomes
The incidence of adverse events
The incidence of adverse events
Secondary Outcomes
- Clinically important changes in ocular safety assessments
- Delay in retinal degeneration
Investigators
Clinical Sciences and Operations
Scientific
Sanofi-Aventis Recherche & Developpement
Study Sites (1)
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