Active — Not RecruitingPhase 2

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

United States, France9 participantsStarted 2013-09-12

Plain-language 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

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

The incidence of adverse events

Timeframe: 15 years

Trial details

NCT IDNCT02065011

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2031-06-13

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