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Efficacy and Safety of Bilateral Intravitreal Injection of GS010: A Randomized, Double-Masked, Placebo-Controlled Trial in Subjects Affected With G11778A ND4 Leber Hereditary Optic Neuropathy for Up to One Year

Trial Profile

Efficacy and Safety of Bilateral Intravitreal Injection of GS010: A Randomized, Double-Masked, Placebo-Controlled Trial in Subjects Affected With G11778A ND4 Leber Hereditary Optic Neuropathy for Up to One Year

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

Latest Information Update: 22 Oct 2019

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At a glance

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

    • 23 Sep 2019 According to a GenSight Biologics media release, An End of Phase II meeting with the U.S. Food and Drug Administration (FDA) has been requested and is expected for November 2019.
    • 24 Jul 2019 According to a GenSight Biologics media release, the End of Phase II meeting with the U.S. Food and Drug Administration (FDA) planned in the Fall remains unchanged and is targeted for September 2019.
    • 11 Jul 2019 According to a GenSight Biologics media release, topline week 52 results are expected to be available in the third quarter of 2020.
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