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.

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Study title: 
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.
Long title: 
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.
Date receipt dossier: 
21 feb 2018
EudraCT number: 
2017-002187-40
Pharmaceutical study code: 
GS010
Company / Sponsor: 
GenSight Biologics
Treated organism: 
Humans
Indication category: 
Genetic disorders
Disease: 
Leber hereditary optic neuropathy
Therapeutic approach: 
Gene therapy
Genetic modification: 
human wild-type MT-NDA (mitochondrial NADH Dehydrogenase 4)
Method of transfer of nucleic acid of interest: 
AAV2
Administered biological material: 
Recombinant AAV2 expressing MT-NDA
Route of administration: 
Intravitreal
Locations in Belgium: 
Universitair Ziekenhuis Gent
Type of procedure: 
Contained use only
Current status: 
Authorized