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NCT04123626Active, not recruitingPhase 1/2

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

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

Source: ClinicalTrials.gov · Last updated 6 May 2022

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
11 (actual)
First submitted
1 Oct 2019
Start date
7 Oct 2019
Primary completion date
7 Jun 2022
Lead sponsor
ProQR Therapeutics
NCT number
NCT04123626

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 11
  • From 7 Oct 2019 to the primary completion date, 7 Jun 2022
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • Main Inclusion Criteria:
  • Male or female, ≥ 18 years of age.
  • Clinical presentation consistent with adRP, based on ophthalmic examinations.
  • Impairment on VF in the opinion of the Investigator, as determined by perimetry.
  • A molecular diagnosis of autosomal dominant form of RP with the P23H mutation in the RHO gene, based on genetic analysis.
  • A clear ocular media and adequate pupillary dilation to permit good quality fundus imaging, as assessed by the Investigator.
    • Main Exclusion Criteria:
  • Presence of additional pathogenic mutations in genes (other than the P23H mutation in the RHO gene) associated with inherited retinal degenerative diseases or syndromes, based on genetic analysis (eg, Usher syndrome, Leber congenital amaurosis, etc).
  • Presence of any significant ocular or non-ocular disease/disorder (including medication and laboratory test abnormalities) which, in the opinion of the Investigator and with concurrence of the Medical Monitor, may either put the subject at risk because of participation in the study, may influence the results of the study, or the subject's ability to participate in the study.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sue Anschutz-Rogers Eye Center, University of Colorado - Dept. of Ophthalmology
Coordinator of this site? Confirm its status
AuroraUnited StatesUnknown status
Retina Foundation of the Southwest
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
VitreoRetinal Associates
Coordinator of this site? Confirm its status
GainesvilleUnited StatesUnknown status
Shriners UK Ophthalmology - University of Kentucky
Coordinator of this site? Confirm its status
LexingtonUnited StatesUnknown status
Casey Eye Institute - OHSU
Coordinator of this site? Confirm its status
PortlandUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.