NCT02161380 - Safety Study of an Adeno-associated Virus Vector for Gene Therapy of Leber's Hereditary Optic Neuropathy | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 14, 2014

Primary Completion Date

March 31, 2023

Study Completion Date

March 31, 2025

Conditions

Leber's Hereditary Optic Neuropathy

Interventions

DRUG

injection of scAAV2-P1ND4v2 1.18x10e9 vg (Low),

injection of Total Volume of each intravitreal injection is 200 µL

DRUG

injection of scAAV2-P1ND4v2 5.81 X10e9 vg (Med)

injection of Total Volume of each intravitreal injection is 200 µL

DRUG

injection of scAAV2-P1ND4v2 2.4 X10e10vg (High)

injection of Total Volume of each intravitreal injection is 100 µL

DRUG

injection of scAAV2-P1ND4v2 1.0 X10e11vg (Higher)

injection of Total Volume of each intravitreal injection is 100 µL

Trial Locations (1)

Bascom Palmer Eye Institute, University of Miami, Miami

All Listed Sponsors

collaborator

National Eye Institute (NEI)

NIH

lead

Byron Lam

OTHER