Sponsored by Sanofi

Phase	Quota	Distance
Phase 1		Near

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

Interventions

• 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