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A Randomized, Double-Masked, Sham-Controlled Clinical Trial to Evaluate the Efficacy of a Single Intravitreal Injection of GS010 in Subjects Affected for 6 Months or Less by LHON Due to the G11778A Mutation in the Mitochondrial ND4 Gene

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Trial Profile

A Randomized, Double-Masked, Sham-Controlled Clinical Trial to Evaluate the Efficacy of a Single Intravitreal Injection of GS010 in Subjects Affected for 6 Months or Less by LHON Due to the G11778A Mutation in the Mitochondrial ND4 Gene

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Jun 2023

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At a glance

  • Drugs Lenadogene nolparvovec (Primary)
  • Indications Leber's hereditary optic atrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms RESCUE
  • Sponsors GenSight Biologics

    • Most Recent Events

    • 27 Apr 2023 Results from REVERSE, RESCUE, RESTORE and REFLECT; comparing visual acuity of Leber hereditary optic neuropathy (LHON) patients treated with lenadogene nolparvovec, presented at the 75th Annual Meeting of the American Academy of Neurology 2023
    • 09 Mar 2023 According to a GenSight Biologics media release, company announced publication of a peer-reviewed article in American Journal of Ophthalmology on pooled safety analysis of lenadogene nolparvovec from five clinical studies (REVEAL, RESCUE, REVERSE, RESTORE and REFLECT).
    • 15 Dec 2022 According to a GenSight Biologics media release, results of pooled analysis of Phase 3 studies, REVERSE, RESCUE and their long-term extension trial RESTORE, as well as the REFLECT trial published in the in the journal Ophthalmology and Therapy
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