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NCT04123626 · ClinicalTrials.gov registry record · Phase 1
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 Phase 1 study of Eye Diseases and Retinal Disease, sponsored by ProQR Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 5
- Study locations
NCT04123626: Active Phase 1 study of Eye Diseases and Retinal Disease, sponsored by ProQR Therapeutics.
NCT04123626 is a Phase 1 study of Eye Diseases and Retinal Disease that is active but no longer recruiting, run by ProQR Therapeutics. The registered enrollment target is 11 participants, below the 741,302-participant average among 27 other Eye Diseases trials with a reported enrollment target (100% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04123626, a Phase 1 study of Eye Diseases and Retinal Disease, is active but no longer recruiting, sponsored by ProQR Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 5
- Study locations
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.
Primary Outcome
Incidence and severity of ocular adverse events scored based on CTCAC in the study and fellow eye
Conditions Studied
Interventions
- OTHER Sham procedure
- DRUG QR-1123
Study Locations (5)
Colorado
- Sue Anschutz-Rogers Eye Center, University of Colorado - Dept. of Ophthalmology - Aurora
Florida
- VitreoRetinal Associates - Gainesville
Kentucky
- Shriners UK Ophthalmology - University of Kentucky - Lexington
Oregon
- Casey Eye Institute, OHSU - Portland
Texas
- Retina Foundation of the Southwest - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2019-10-07 |
| Est. Completion | 2022-06-07 |
| Phase | Phase 1 |
What the registry record for NCT04123626 still lists
NCT04123626 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 741,302-participant average among 27 other Eye Diseases trials with a reported enrollment target (100% lower).
The record links to 8 conditions, with Eye Diseases appearing as the primary indexed condition, and to 2 interventions - of which Sham procedure is the first listed.
NCT04123626 lists 5 locations in 5 states (Colorado, Florida, Kentucky).
Frequently Asked Questions
What is clinical trial NCT04123626 about?
NCT04123626 is a clinical study titled "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". 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 dou...
What is the current status of trial NCT04123626?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2019-10-07. Estimated completion is 2022-06-07.
What conditions does trial NCT04123626 study?
This clinical trial studies the following conditions: Eye Diseases, Retinal Disease, Eye Diseases, Hereditary, Retinal Dystrophies, Vision Disorders.
What interventions are being tested in trial NCT04123626?
The interventions under investigation include: Sham procedure (OTHER), QR-1123 (DRUG).
Who is sponsoring clinical trial NCT04123626?
This trial is sponsored by ProQR Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04123626 being conducted?
This trial has 5 study locations across Colorado, Florida, Kentucky, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Eye Diseases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04123626's enrollment target sits among peer trials
11 28th of 27 the lowest of 27 other Eye Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Eye Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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