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NCT07796646
Study to Evaluate the Long-Term Safety of Ultevursen in Participants With Retinitis Pigmentosa (RP) Due to Mutations in Exon 13 of the USH2A Gene
Conditions: Retinitis Pigmentosa (RP), Usher Syndrome Type 2, Deaf Blind, Retinal Disease, Eye Diseases, Hereditary, Eye Disorders Congenital, Vision Disorders
Sex: All
Ages: 8 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 81
Sponsor: Laboratoires Thea
Summary
The purpose of this Phase 2 Open-label study is to evaluate the long-term safety and tolerability of Ultevursen administered via intravitreal injection (IVT) in participants with Retinitis Pigmentosa due to mutations in exon 13 of the USH2A gene. This is a multicenter study which will enroll approximately 81 participants, however, the exact number enrolled will depend on the final number completing the 24-month LUNA trial and are eligible and willing to enroll in CAPELLA.
Eligibility Criteria
Inclusion Criteria:
1. Participants who have completed the LUNA study through Month 24 and, in the Investigator's judgment, may benefit from continued treatment or observational follow-up
2. Be adults (≥18 years old) who are able to provide informed consent OR minors (8 to \
Source: ClinicalTrials.gov (NCT07796646). StuddyBuddy aggregates publicly available trial information.
