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Study to Evaluate Safety of RTx-015 Injection in Retinitis Pigmentosa or Choroideremia Patients (ENVISION)

StatusActive, Not Recruiting
PhasePhase 1
Started
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Record History

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  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 18 to confirmed 10
    • Site details revised at 4 of 4 sites
    v7
  2. Notable Primary and study completion dates: May 2026 to Oct 2030v6 Show 4 more changesShow less
    • Enrollment target: 15 to 18
    • Study sites: 3 to 4
    • Study description revised
    • Study arms: 3 to 4
  3. Notable Enrollment target: 9 to 15v5 Show 4 more changesShow less
    • Eligibility criteria expanded, about 9 words
    • Site contacts updated at 2 of 3 sites
    • Study description expanded, about 2 words
    • Study title expanded, about 2 words
  4. Minor Study sites: 2 to 3v4
  5. Minor Start date changed from estimate of Aug 2024 to Aug 27, 2024
    • Site details revised at 1 of 2 sites
    v3
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 2 of 2 sites
    • Study title expanded, about 1 word
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A Phase 1, open-label, non-randomized, dose-escalation study, where approximately 18 eligible patients with retinitis pigmentosa or choroideremia will be enrolled sequentially in up to 4 dose cohorts of RTx-015. Enrolled patients will receive a single, unilateral intravitreal injection of RTx-015 in the study eye at Visit 3 (Day 0) and be followed for a total of 5 years.
Trial Details
NCT Number NCT06460844
Lead Sponsor Ray Therapeutics, Inc.
Conditions
(from sponsor)
Retinitis Pigmentosa, Choroideremia
Related terms Choroideremia, Retinitis Pigmentosa
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov