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ACTIVE NOT RECRUITING
NCT04123626
PHASE1/PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

QR-1123

unilateral IVT injection

OTHER

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