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
Price :
$35
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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
- 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