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Phase 3 Study to Evaluate the Safety and Efficacy of AAV5-hRKp.RPGR for the Treatment of Japanese X-linked Retinitis Pigmentosa Associated With Pathogenic Variants in Retinitis Pigmentosa GTPase Regulator (RPGR)

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Trial Profile

Phase 3 Study to Evaluate the Safety and Efficacy of AAV5-hRKp.RPGR for the Treatment of Japanese X-linked Retinitis Pigmentosa Associated With Pathogenic Variants in Retinitis Pigmentosa GTPase Regulator (RPGR)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Jun 2025

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At a glance

  • Drugs Botaretigene sparoparvovec (Primary)
  • Indications Retinitis pigmentosa
  • Focus Adverse reactions; Registrational
  • Sponsors Janssen Pharmaceutical KK; Johnson & Johnson Innovative Medicine

Most Recent Events

  • 27 Jun 2025 Planned End Date changed from 17 May 2030 to 12 Nov 2030.
  • 04 Dec 2024 Planned End Date changed from 7 Feb 2030 to 17 May 2030.
  • 14 Aug 2024 Planned End Date changed from 9 Oct 2029 to 7 Feb 2030.

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