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An Open Label Dose Escalation Clinical Trial to Evaluate the Safety and the Tolerability of GS010 (rAAV2/2-ND4) in Patients With Leber Hereditary Optic Neuropathy Due to Mutations in the Mitochondrial NADH Dehydrogenase 4 Gene

Trial Profile

An Open Label Dose Escalation Clinical Trial to Evaluate the Safety and the Tolerability of GS010 (rAAV2/2-ND4) in Patients With Leber Hereditary Optic Neuropathy Due to Mutations in the Mitochondrial NADH Dehydrogenase 4 Gene

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 27 Feb 2019

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At a glance

  • Drugs Lenadogene nolparvovec (Primary)
  • Indications Leber's hereditary optic atrophy
  • Focus Adverse reactions
  • Sponsors GenSight Biologics
  • Most Recent Events

    • 12 Feb 2019 According to a GenSight Biologics media release, detailed safety data from this study were published in the Journal of the American Medical Association (JAMA) Ophthalmology.
    • 12 Feb 2019 Results of a secondary analysis of this trial presented in a GenSight Biologics media release.
    • 20 Feb 2018 According to a GenSight Biologics media release, results will be presented at the North American Neuro-Ophthalmology Society (NANOS) conference, March 2018 and at the the Association for Research in Vision and Ophthalmology (ARVO) conference, May 2018.
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