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A Follow-on Study for Second-Eye Treatment for Participants Previously Treated With Gene Therapy for X-Linked Retinitis Pigmentosa (XLRP)

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Sponsor changed: Janssen Research & Development, LLC to MeiraGTx Ocular UK Ltd
    • Eligibility criteria expanded, about 3 words
  2. Minor 6 versions Re-verified since Mar 12, 2026, no change to tracked fieldsv18-v23
  3. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 42 to confirmed 24
    • Site details revised at 3 of 3 sites
    v17
  4. Minor Site details revised at 2 of 3 sitesv16
  5. Minor 3 versions Re-verified since Oct 9, 2025, no change to tracked fieldsv13-v15
Show 11 earlier versionsHide 11 earlier versions
  1. Notable Primary endpoints: 1 to 3
    • Enrollment target: 39 to 42
    • Secondary endpoints shortened, about 100 words
    v12
  2. Minor Study sites: 2 to 3v11
  3. Minor 4 versions Re-verified since Mar 29, 2025, no change to tracked fieldsv7-v10
  4. Notable Primary endpoints: 2 to 1
    • Secondary endpoints: 8 to 7
    v6
  5. Minor Study sites: 1 to 2v5
  6. Minor Re-verified, no change to tracked fieldsv4
  7. Minor Enrollment target: 42 to 39v3
  8. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 11, 2024 to Oct 10, 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to assess the safety and tolerability of subretinal delivery of Adeno-associated Virus Vector (AAV5 hRKp.RPGR) gene therapy in adults and children with X-linked retinitis pigmentosa.
Trial Details
NCT Number NCT06646289
Lead Sponsor MeiraGTx Ocular UK Ltd
Conditions
(from sponsor)
X-Linked Retinitis Pigmentosa
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov