A study to determine the long-term safety, tolerability and biological activity of UshStat® in Usher syndrome type 1B

Sponsored by Sanofi

Phase Quota
Phase 1

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

Study Start Date: September 2013

Estimated Completion Date: October 2032

Specialties: Ophthalmology: Low Vision,Retina Otolaryngology: Otology/Neurotology


  • Drug: UshStat

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 UshStat®

Exclusion criteria

  • Did not receive UshStat® as part of the TDU13600 protocol

Study Locations And Contact Information

  • Investigational Site Number 250001, Paris
  • Investigational Site Number 840001, Portland Oregon

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