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Study to Evaluate Ultevursen in Subjects With Retinitis Pigmentosa (RP) Due to Mutations in Exon 13 of the USH2A Gene
NCT06627179 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06627179
The ClinicalTrials.gov registry entry for NCT06627179 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Laboratoires Thea, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06627179 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06627179?
This trial is sponsored by Laboratoires Thea, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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