Clinical Trial

Study to Evaluate Ultevursen in Subjects With Retinitis Pigmentosa (RP) Due to Mutations in Exon 13 of the USH2A Gene

Study acronym: LUNA
Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-07-10
notable Primary completion pushed: 2027-12 -> 2028-07 2026-07-10
minor Completion pushed: 2027-12 -> 2028-07 2026-07-10
Trial Details
NCT Number NCT06627179
Lead Sponsor Laboratoires Thea
Collaborators: Sepul Bio
Conditions Retinitis Pigmentosa (RP), Usher Syndrome Type 2, Deaf Blind, Retinal Disease, Eye Diseases, Hereditary, Eye Disorders Congenital, Vision Disorders
Enrollment 81 participants
Start Date 2024-12-11
Primary Completion 2028-07 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2026-07-09