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

Study acronym: LUNA
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary and study completion pushed from Dec 2027 to Jul 2028
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Study sites: 28 to 26
    v22
  2. Study sites: 27 to 28v21
  3. Study sites: 26 to 27v20
  4. Study sites: 25 to 26v19
  5. Study sites: 24 to 25v18
Show 16 earlier versionsHide 16 earlier versions
  1. Study sites: 21 to 24v17
  2. Study sites: 20 to 21v16
  3. Study sites: 19 to 20v15
  4. Study sites: 14 to 19v14
  5. Study sites: 13 to 14v13
  6. Study sites: 10 to 13v12
  7. Study sites: 7 to 10v11
  8. Eligibility criteria shortened, about 16 words
    • Secondary endpoints: 13 to 10
    • Study description revised
    • Site contacts updated at 7 of 7 sites
    v10
  9. Study sites: 6 to 7v9
  10. Study sites: 4 to 6v8
  11. Study sites: 3 to 4v7
  12. Study sites: 2 to 3v6
  13. Study sites: 1 to 2v5
  14. Site contact updatedv4
  15. Start date changed from estimate of Dec 9, 2024 to Dec 11, 2024
    • Site contact updated
    v3
  16. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date: Dec 2024 to Dec 9, 2024
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06627179
Lead Sponsor Laboratoires Thea
Collaborators: Sepul Bio
Conditions
(from sponsor)		 Retinitis Pigmentosa (RP), Usher Syndrome Type 2, Deaf Blind, Retinal Disease, Eye Diseases, Hereditary, Eye Disorders Congenital, Vision Disorders
Related terms Eye Abnormalities, Eye Diseases, Hereditary, Retinal Diseases, Retinitis Pigmentosa, Usher Syndromes, Vision Disorders
Enrollment 81 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov