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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

Study acronym: AURORA
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 6, 2022 (before its estimated June 7, 2022 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 35 to confirmed 11
    • Primary and study completion dates: Jul 1, 2022 to Jun 7, 2022
    • Site details revised at 5 of 5 sites
    v11
  2. Primary and study completion dates: Oct 7, 2021 to Jul 1, 2022v10
  3. Site contacts updated at 2 of 5 sitesv9
  4. Eligibility criteria revised
    • Secondary endpoints: 12 to 9
    • Study arms: 5 to 6
    v8
  5. Study sites revised (5)v7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 4 to 5v6
  2. Study sites: 3 to 4v5
  3. Re-verified, no change to tracked fieldsv4
  4. Study sites: 2 to 3v3
  5. Study sites: 1 to 2v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04123626
Lead Sponsor ProQR Therapeutics
Conditions
(from sponsor)		 Autosomal Dominant Retinitis Pigmentosa, Eye Diseases, Eye Diseases, Hereditary, Retinal Dystrophies, Retinal Disease, Retinitis, Vision Tunnel, Vision Disorders
Related terms Eye Diseases, Eye Diseases, Hereditary, Multiple Pterygium Syndrome, Autosomal Dominant, Night Blindness, Congenital Stationary, Autosomal Dominant 1, Retinal Diseases, Retinal Dystrophies, Retinitis, Retinitis Pigmentosa, Vision Disorders
Enrollment 11 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov