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
- Diseases
- Retinitis pigmentosa
- 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
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sue Anschutz-Rogers Eye Center, University of Colorado - Dept. of Ophthalmology Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Retina Foundation of the Southwest Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| VitreoRetinal Associates Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Shriners UK Ophthalmology - University of Kentucky Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Casey Eye Institute - OHSU Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.