NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration

Inclusion criteria

• . Subjects ≥ 50 and ≤ 89 years of age with a diagnosis of active subfoveal CNV secondary to wAMD in the Study Eye
• . BCVA between 20/40 and 20/400 in the Study Eye, with BCVA decrement primarily attributable to wAMD
• . Administration of at least 3 anti-VEGF (vascular endothelial growth factor) injections in the study eye in the past 6 months for clinically active wAMD, the most recent of which was within 1 month prior to Screening Day -14 (Visit 1).
• . Must be pseudo phakic (status post cataract surgery) in the Study Eye
• . Female and Male reproductive status: Female subjects must be either: (1) of non-childbearing potential; or (2) of childbearing potential and using an acceptable method of birth control with a negative pregnancy test. Male subjects agree to refrain from sperm donations and practice contraception to avoid any pregnancy for 3 months after administration of NG101.
• . Normal blood pressure (BP) and heart rate (HR), or near normal BP and HR not considered clinically significant (NCS) by the Investigator at the Screening Day -14 (Visit 1) and Day -7 (Visit 2)
• . Willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to the performance of any study-related procedures
• . Willingness and ability to comply with schedule for follow-up visits and postoperative evaluations

Exclusion criteria