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A Phase 3 Study Of OCU400 Gene Therapy for the Treatment Of Retinitis Pigmentosa

Study acronym: liMeliGhT
StatusActive, Not Recruiting
PhasePhase 3
SponsorOcugen
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv14
  2. Notable Primary endpoints: 2 to 1v13 Show 4 more changesShow less
    • Enrollment target: estimated 150 to confirmed 140
    • Primary and study completion dates: Dec 31, 2026 to Feb 12, 2027
    • Secondary endpoints: 5 to 4
    • Study description shortened, about 6 words
  3. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 17 of 17 sites
    v12
  4. Minor Eligibility criteria revisedv11
  5. Minor Site details revised at 1 of 17 sitesv10
Show 8 earlier versionsHide 8 earlier versions
  1. Notable Primary completion date: Jun 30, 2025 to Dec 31, 2026
    • Study sites: 16 to 17
    • Study completion date: Oct 30, 2026 to Dec 31, 2026
    v9
  2. Minor Study sites: 15 to 16
    • Eligibility criteria expanded, about 2 words
    v8
  3. Minor Site details revised at 1 of 15 sitesv7
  4. Minor Site contacts updated at 1 of 15 sitesv6
  5. Minor Site details revised at 5 of 15 sitesv5
  6. Minor Site contacts updated at 1 of 15 sitesv4
  7. Minor Study sites: 5 to 15v3
  8. Minor Study sites: 2 to 5
    • Start date changed from estimate of Apr 26, 2024 to Jun 18, 2024
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
6 trials monitored
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This is a Phase 3 study to Assess the Efficacy, Safety and Tolerability of OCU400 in patients with retinitis pigmentosa (RP) associated with RHO mutations and patients with any other RP associated mutation with a clinical phenotype of RP. This is a multicenter, assessor blinded and randomized study which will enroll 140 subjects. Study has completed enrollment of all 140 subjects.
Trial Details
NCT Number NCT06388200
Lead Sponsor Ocugen
Conditions
(from sponsor)
Retinitis Pigmentosa
Related terms Retinitis Pigmentosa
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov