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Efficacy and Safety of Gene Therapy rAAV-RPE65 (LX101) in Biallelic RPE65 Mutation-associated Inherited Retinal Dystrophy: a Phase III, Multicenter, Randomized Controlled Trial (STAR)

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Trial Profile

Efficacy and Safety of Gene Therapy rAAV-RPE65 (LX101) in Biallelic RPE65 Mutation-associated Inherited Retinal Dystrophy: a Phase III, Multicenter, Randomized Controlled Trial (STAR)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Jul 2025

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At a glance

  • Drugs LX 101 Innostellar Biotherapeutics (Primary)
  • Indications Retinal dystrophies
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms STAR
  • Sponsors Innostellar Biotherapeutics

Most Recent Events

  • 17 Jul 2025 New trial record
  • 14 Jul 2025 According to Innostellar Biotherapeutics media release, top-line results expected in Q4 2025 and initiate NMPA New Drug Application soon after.

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