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: 23 Mar 2024
Price :
$35
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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
- 20 Mar 2024 Initial efficacy and safety results at 4 years a post-treatment administration in the REFLECT Phase III clinical trial with LUMEVOQ (GS010; lenadogene nolparvovec), presented in a GenSight Biologics media release.
- 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
- 19 Apr 2023 Results assessing the efficacy and safety of bilateral intravitreal injection of lenadogene nolparvovec in patients with a confirmed m.11778G>A mutation, using a recombinant adeno-associated virus vector 2, serotype 2 (rAAV2/2-ND4), published in the Brain.