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 20/63 and 20/400 in the Study Eye, with BCVA decrement primarily attributable to wAMD Administration of at least 3 anti-VEGF injections in the past 6 months, the most recent of which was within 2 months prior to Screening. Must be pseudo phakic (status post cataract surgery) in the Study Eye 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: 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: CNV or macular edema in the Study Eye secondary to any causes other than AMD Any condition preventing visual acuity improvement in the Study Eye, e.g., fibrosis, atrophy, or retinal pigment epithelial tear in the center of the macula Any ophthalmic condition that precludes adequate ophthalmic examination or requires ancillary testing Retinal detachment or history of retinal detachment in the Study Eye Active uncontrolled glaucoma with intraocular pressure (IOP) ≥ 30 mmHg despite treatment with more than 2 glaucoma medications, advanced glaucoma with cup-to-disc ratio of ≥ 0.9, visual field defects secondary to glaucoma that involve the macula, and/or optic atrophy from glaucoma History of intravitreal therapy in the Study Eye, such as intravitreal steroid injection or an investigational product, other than anti-VEGF therapy, in the 6 months prior to Screening History of vitrectomy, trabeculectomy, glaucoma tube-shunt procedure, minimally invasive glaucoma surgery (MIGS) device, or other filtration surgery in the Study Eye Any prior treatment with photodynamic therapy or retinal laser for the treatment of wAMD Any prior therapeutic radiation in the region of the Study Eye such as whole brain radiation, proton beam radiation, gamma knife treatment, or plaque brachytherapy Any previous intraocular or refractive surgery on the Study Eye within 6 months Any previous gene therapy in the Study Eye Presence of an ocular implant in the Study Eye at Screening, excluding intraocular lens and custom flex iris prosthesis Any diabetic retinopathy or other retinal vascular disease including retinal vein occlusion, retinal artery occlusion, retinal arterial macro aneurysm, ocular ischemic syndrome, retinal vasculitis, vitritis, posterior uveitis Any medically uncontrolled diabetes, defined as HbA1C > 8.0 History of ocular melanoma History of any known inherited retinal disease Currently taking any anticoagulant therapy, which is deemed medically necessary and cannot be permanently stopped at least 2 weeks prior to NG101 injection, excluding prophylactic low-dose aspirin therapy Any underlying systemic diseases as severe cardiovascular, cerebrovascular, and neurodegenerative diseases, including active malignancy and immunocompromised conditions. Active hepatitis B or C History of human immunodeficiency virus (HIV), active tuberculosis, and/or syphilis Any significant illness that would preclude study compliance and follow-up Subjects who, in the Investigator's opinion, lack the mental capacity to provide written informed consent for study participation