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A Clinical Trial Evaluating the Safety and Efficacy of a Single Subretinal Injection of AGTC-501 in Participants With XLRP

StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 7, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Aug 2025 to Jun 30, 2026
    • Study sites: 24 to 25
    • Study completion date: Oct 2029 to Oct 31, 2031
    v21
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 75 to confirmed 85
    • Site details revised at 24 of 24 sites
    v20
  3. Site contacts updated at 1 of 24 sitesv19
  4. Site details revised at 1 of 24 sitesv18
  5. Study sites: 21 to 24
    • Eligibility criteria shortened, about 33 words
    • Secondary endpoints: 19 to 3
    v17
Show 15 earlier versionsHide 15 earlier versions
  1. Study sites: 20 to 21v16
  2. Study sites: 16 to 20v15
  3. Study sites: 15 to 16v14
  4. Study sites: 14 to 15v13
  5. Study sites: 13 to 14v12
  6. Study sites: 10 to 13v11
  7. Study sites: 9 to 10v10
  8. Study sites: 7 to 9v9
  9. Study sites: 6 to 7v8
  10. Study sites: 4 to 6v7
  11. Study sites: 3 to 4v6
  12. Study sites: 2 to 3v5
  13. Re-verified, no change to tracked fieldsv4
  14. Trial status: Not Yet Recruiting to Recruitingv3 Show 11 more changesShow less
    • Primary completion date: Jan 2024 to Aug 2025
    • Start date changed from estimate of Aug 2021 to Mar 14, 2024
    • Primary endpoint revised
    • Enrollment target: 63 to 75
    • Study sites: 0 to 2
    • Study completion date: Mar 2029 to Oct 2029
    • Interventions: rAAV2tYF-GRK1-hRPGRco (Biological) to Control (Drug), rAAV2tYF-GRK1-hRPGRco (Biological)
    • Eligibility criteria expanded, about 485 words
    • Secondary endpoints: 5 to 19
    • Study description shortened, about 13 words
    • Study title shortened, about 6 words
  15. Study sites: 15 to 0v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study will evaluate and compare the safety, efficacy, and tolerability of 2 doses of a recombinant adeno-associated virus vector (AGTC-501/laruparetigene zovaparvovec )) to an untreated control group in male participants with X-linked retinitis pigmentosa caused by RPGR mutations.
Trial Details
NCT Number NCT04850118
Lead Sponsor Beacon Therapeutics
Conditions
(from sponsor)		 X-Linked Retinitis Pigmentosa
Related terms Retinal Degeneration
Enrollment 85 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov