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Follow-up Gene Therapy Trial for the Treatment of X-linked Retinitis Pigmentosa Associated With Variants in the RPGR Gene

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

Record History

See every version on ClinicalTrials.gov ↗

  1. Sponsor changed: Janssen Research & Development, LLC to MeiraGTx Ocular UK Ltd
    • Site details revised at 2 of 28 sites
    • Eligibility criteria expanded, about 2 words
  2. 3 versions Re-verified since Jun 4, 2026, no change to tracked fieldsv43-v45
  3. Trial sites expanded: 25 → 28 locationsv42
  4. 2 versions Re-verified since Mar 12, 2026, no change to tracked fieldsv40-v41
  5. Study sites: 28 to 25v39
Show 37 earlier versionsHide 37 earlier versions
  1. Study completion date: Dec 19, 2029 to Dec 7, 2029v38
  2. 3 versions Re-verified since Oct 9, 2025, no change to tracked fieldsv35-v37
  3. Primary endpoints: 3 to 4
    • Secondary endpoints shortened, about 200 words
    v34
  4. 13 versions Re-verified since Jul 15, 2024, no change to tracked fieldsv21-v33
  5. Study sites revised (28)v20
  6. Re-verified, no change to tracked fieldsv19
  7. Study sites revised (28)v18
  8. Re-verified, no change to tracked fieldsv17
  9. Study completion date: Sep 20, 2029 to Dec 19, 2029v16
  10. Primary endpoints: 2 to 3v15 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Interventions: Genetic: AAV5-RPGR 2e11 (Biological), Genetic: AAV5-RPGR 4e11 (Biological) to Genetic: AAV5-hRKp.RPGR Intermediate Dose (Biological), Genetic: AAV5-hRKp.RPGR Low Dose (Biological)
    • Eligibility criteria revised
    • Secondary endpoints: 7 to 12
    • Site details revised at 28 of 28 sites
  11. Lead sponsor: MeiraGTx UK II Ltd to Janssen Research & Development, LLCv14 Show 5 more changesShow less
    • Trial status: Active, Not Recruiting to Recruiting
    • Primary and study completion dates: Sep 2029 to Sep 20, 2029
    • Start date: Mar 16, 2021 to Dec 4, 2020
    • Study sites revised (28)
    • Collaborators shortened, about 5 words
  12. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 96 to confirmed 97
    • Primary and study completion dates: May 2029 to Sep 2029
    • Site details revised at 28 of 28 sites
    v13
  13. Site contacts updated at 1 of 28 sitesv12
  14. Study sites: 24 to 28v11
  15. Study sites: 20 to 24v10
  16. Study sites: 16 to 20v9
  17. Primary completion date: Oct 2024 to May 2029v8 Show 4 more changesShow less
    • Primary endpoints: 1 to 2
    • Enrollment target: 66 to 96
    • Study completion date: Oct 2028 to May 2029
    • Secondary endpoints revised (7)
  18. Study sites: 12 to 16v7
  19. Study sites: 10 to 12v6
  20. Primary completion date: Jul 5, 2023 to Oct 2024
    • Study sites: 6 to 10
    • Study completion date: Jul 5, 2027 to Oct 2028
    v5
  21. Enrollment target: 60 to 66
    • Study sites: 5 to 6
    • Eligibility criteria revised
    v4
  22. Site contacts updated at 1 of 5 sitesv3
  23. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Enrollment target: 48 to 60
    • Study sites: 0 to 5
    • Start date changed from estimate of Mar 1, 2022 to Mar 16, 2021
    • Interventions: Genetic: AAV5-RPGR (Biological) to Genetic: AAV5-RPGR 2e11 (Biological), Genetic: AAV5-RPGR 4e11 (Biological)
    • Secondary endpoints revised (7)
    • Study arms: 2 to 3
  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.
A clinical trial of AAV5-hRKp.RPGR vector for participants with X-linked retinitis pigmentosa (XLRP)
Trial Details
NCT Number NCT04794101
Lead Sponsor MeiraGTx Ocular UK Ltd
Conditions
(from sponsor)		 X-Linked Retinitis Pigmentosa
Enrollment 97 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov