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A Study of AAV5-hRKp.RPGR for the Treatment of Japanese Participants With X-linked Retinitis Pigmentosa

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Sponsor changed: Janssen Pharmaceutical K.K. to MeiraGTx Ocular UK Ltd
    • Eligibility criteria expanded, about 7 words
    • Publications: details revised at 1 of 1 entry
  2. Minor 4 versions Re-verified since May 7, 2026, no change to tracked fieldsv31-v34
  3. Minor Trial status changed: Recruiting → Active, Not Recruiting
    • Site details revised
    v30
  4. Minor 4 versions Re-verified since Dec 12, 2025, no change to tracked fieldsv26-v29
  5. Notable Primary completion date: Sep 16, 2025 to Jun 30, 2027
    • Secondary endpoints: 11 to 3
    v25
Show 23 earlier versionsHide 23 earlier versions
  1. Minor 2 versions Re-verified since Jul 17, 2025, no change to tracked fieldsv23-v24
  2. Minor Study completion date: May 17, 2030 to Nov 12, 2030v22
  3. Minor 5 versions Re-verified since Jan 22, 2025, no change to tracked fieldsv17-v21
  4. Minor Study completion date: Feb 7, 2030 to May 17, 2030v16
  5. Minor 2 versions Re-verified since Sep 10, 2024, no change to tracked fieldsv14-v15
  6. Minor Study completion date: Oct 9, 2029 to Feb 7, 2030v13
  7. Minor 4 versions Re-verified since Apr 23, 2024, no change to tracked fieldsv9-v12
  8. Minor Study completion date: May 10, 2029 to Oct 9, 2029v8
  9. Minor Re-verified, no change to tracked fieldsv7
  10. Notable Primary completion date: Sep 14, 2024 to Sep 16, 2025
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: 7 to 11
    v6
  11. Minor 2 versions Re-verified since Nov 7, 2023, no change to tracked fieldsv4-v5
  12. Minor Start date changed from estimate of Aug 21, 2023 to Sep 12, 2023v3
  13. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jul 24, 2023 to Aug 21, 2023
    • Site details revised
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of the study is to assess the safety and tolerability of bilateral subretinal delivery of adeno-associated virus vector with a serotype 5 capsid human rhodopsin kinase promoter. retinitis pigmentosa guanosine triphosphatase regulator (AAV5-hRKp.RPGR).
Trial Details
NCT Number NCT05926583
Lead Sponsor MeiraGTx Ocular UK Ltd
Conditions
(from sponsor)
Retinitis Pigmentosa
Related terms Retinitis Pigmentosa
Enrollment 4 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov