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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

NCT04123626 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2022-05-06

No results posted yet for this study

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.

Conditions

  • Autosomal Dominant Retinitis Pigmentosa
  • Eye Diseases
  • Eye Diseases, Hereditary
  • Retinal Dystrophies
  • Retinal Disease
  • Retinitis
  • Vision Tunnel
  • Vision Disorders

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

Sponsors & Collaborators

  • ProQR Therapeutics

    lead INDUSTRY

Principal Investigators

  • ProQR Medical Monitor · ProQR Therapeutics

  • ProQR Clinical Trial Manager · ProQR Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-07
Primary Completion
2022-06-07
Completion
2022-06-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04123626 on ClinicalTrials.gov