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A Study to Evaluate the Safety and Tolerability of QR-1123 in Subjects With Autosomal Dominant Retinitis Pigmentosa Due to the P23H Mutation in the RHO Gene
Sponsor: ProQR Therapeutics
Summary
This study evaluates the safety, tolerability and efficacy of QR-1123 injection in the eye (intravitreal; IVT) injections (one eye/unilateral) in subjects receiving a single dose or repeat doses. Single injections will be assessed in an open label way, and repeat injections will be assessed in a double-masked, randomized, sham-controlled fashion.
Official title: A Prospective First-In-Human Study to Evaluate the Safety and Tolerability of QR-1123 in Subjects With Autosomal Dominant Retinitis Pigmentosa (adRP) Due to the P23H Mutation in the RHO Gene
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
11
Start Date
2019-10-07
Completion Date
2022-06-07
Last Updated
2022-05-06
Healthy Volunteers
No
Conditions
Interventions
QR-1123
unilateral IVT injection
Sham procedure
Sham procedures (i.e. no penetration of the globe) closely mimic the active injection and serve to mask subjects to treatment assignment
Locations (5)
Sue Anschutz-Rogers Eye Center, University of Colorado - Dept. of Ophthalmology
Aurora, Colorado, United States
VitreoRetinal Associates
Gainesville, Florida, United States
Shriners UK Ophthalmology - University of Kentucky
Lexington, Kentucky, United States
Casey Eye Institute, OHSU
Portland, Oregon, United States
Retina Foundation of the Southwest
Dallas, Texas, United States