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NCT06627179 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate Ultevursen in Subjects With Retinitis Pigmentosa (RP) Due to Mutations in Exon 13 of the USH2A Gene
A Phase 2 study of Retinal Disease and Eye Diseases, Hereditary, sponsored by Laboratoires Thea.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
- 20
- Study locations
NCT06627179: Recruiting Phase 2 study of Retinal Disease and Eye Diseases, Hereditary, sponsored by Laboratoires Thea.
NCT06627179 is a Phase 2 study of Retinal Disease and Eye Diseases, Hereditary that is actively recruiting participants, run by Laboratoires Thea. The registered enrollment target is 81 participants, below the 1,237-participant average among 19 other Retinal Disease trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06627179, a Phase 2 study of Retinal Disease and Eye Diseases, Hereditary, is actively recruiting participants, sponsored by Laboratoires Thea.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this Phase 2b study is to evaluate the 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. This is a multicenter Double-masked, Randomized, Sham-controlled study which will enroll 81 subjects.
Primary Outcome
Annualized percent change from baseline in ellipsoid zone (EZ) width as measured by spectral-domain optical coherence tomography (SD-OCT) up to Month 24.
Conditions Studied
Interventions
- DRUG Intravitreal Injection of Ultevursen
- OTHER No intervention, will not receive any active study intervention
Study Locations (20)
Other
- Ghent University Hospital - Ghent
- Federal University of São Paulo - Hospital São Paulo (UNIFESP-HSP) - São Paulo
- Rigshospitalet and University of Copenhagen - Glostrup Municipality
- Hôpital Gui de Chauliac - CHRU de Montpellier - Maladies Sensorielles Génétique - Montpellier
- Centre de maladies rares CHNO des Quinze Vingt - Paris
- Universitätsklinikum Tübingen - Tübingen
- ASST Santi Paolo e Carlo Hospital, University of Milan - Milan
- AOU Università degli Studi della Campania Luigi Vanvitelli - Naples
Texas
- Retina Foundation of the Southwest - Dallas
- Baylor College of Medicine - Houston
California
- The University of California, San Francisco - San Francisco
Florida
- Bascom Palmer Eye Institute/University of Miami - Miami
Georgia
- Emory University - Atlanta
Massachusetts
- Massachusetts Eye and Ear - Boston
Michigan
- University of Michigan- Kellogg Eye Center - Ann Arbor
Oregon
- Casey Eye Institute, Oregon Health & Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2024-12-11 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
What NCT06627179 shows while recruiting
NCT06627179 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 1,237-participant average among 19 other Retinal Disease trials with a reported enrollment target (93% lower).
The record links to 7 conditions, with Retinal Disease appearing as the primary indexed condition, and to 2 interventions - of which Intravitreal Injection of Ultevursen is the first listed.
NCT06627179 names 20 study sites across 12 states, led by Other, Texas, California.
Frequently Asked Questions
What is clinical trial NCT06627179 about?
NCT06627179 is a clinical study titled "Study to Evaluate Ultevursen in Subjects With Retinitis Pigmentosa (RP) Due to Mutations in Exon 13 of the USH2A Gene". The purpose of this Phase 2b study is to evaluate the 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. This is a multicenter Double-masked, Randomized, Sham-controlled study w...
What is the current status of trial NCT06627179?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2024-12-11. Estimated completion is 2027-12.
What conditions does trial NCT06627179 study?
This clinical trial studies the following conditions: Retinal Disease, Eye Diseases, Hereditary, Vision Disorders, Eye Disorders Congenital, Retinitis Pigmentosa (RP).
What interventions are being tested in trial NCT06627179?
The interventions under investigation include: Intravitreal Injection of Ultevursen (DRUG), No intervention, will not receive any active study intervention (OTHER).
Who is sponsoring clinical trial NCT06627179?
This trial is sponsored by Laboratoires Thea, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06627179 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06627179's enrollment target sits among peer trials
81 10th of 19 higher than 10 of 19 other Retinal Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Retinal Disease 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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