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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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Feb 2019

At a glance

  • Drugs GS 010 (Primary)
  • Indications Leber's hereditary optic atrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms REFLECT
  • Sponsors GenSight Biologics
  • Most Recent Events

    • 13 Sep 2018 According to a GenSight Biologics media release, based on the Special Protocol Assessment (SPA) and interim results of the study, BLA submission in the US is targeted for H2 2020.
    • 13 Sep 2018 According to a GenSight Biologics media release, this trial is covered by a Special Protocol Assessment (SPA) with the FDA.
    • 05 Apr 2018 Status changed from not yet recruiting to recruiting.
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