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NCT05158296 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Efficacy Safety and Tolerability of Ultevursen in Subjects With RP Due to Mutations in Exon 13 of the USH2A Gene (Sirius)
A Phase 2 study, sponsored by Laboratoires Thea.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT05158296: Clinical Trial Phase 2 study, sponsored by Laboratoires Thea.
NCT05158296 is a Phase 2 study that was terminated before completion, run by Laboratoires Thea. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05158296, a Phase 2 study, was terminated before completion, sponsored by Laboratoires Thea.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy safety and tolerability of ultevursen administered via intravitreal injection (IVT) in subjects with Retinitis Pigmentosa (RP) due to mutations in exon 13 of the USH2A gene.
Primary Outcome
Mean change from baseline in best corrected visual acuity(BCVA) based on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart
Interventions
- OTHER Sham-procedure
- DRUG Ultevursen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2021-12-08 |
| Est. Completion | 2022-10-12 |
| Phase | Phase 2 |
Why NCT05158296 stopped before completion
NCT05158296 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham-procedure is the first listed.
NCT05158296 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05158296 about?
NCT05158296 is a clinical study titled "Study to Evaluate the Efficacy Safety and Tolerability of Ultevursen in Subjects With RP Due to Mutations in Exon 13 of the USH2A Gene (Sirius)". The purpose of this study is to evaluate the efficacy safety and tolerability of ultevursen administered via intravitreal injection (IVT) in subjects with Retinitis Pigmentosa (RP) due to mutations in exon 13 of the USH2A gene.
What is the current status of trial NCT05158296?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2021-12-08. Estimated completion is 2022-10-12.
What interventions are being tested in trial NCT05158296?
The interventions under investigation include: Sham-procedure (OTHER), Ultevursen (DRUG).
Who is sponsoring clinical trial NCT05158296?
This trial is sponsored by Laboratoires Thea, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05158296's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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