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

Eligibility Criteria

• 1. Subjects ≥ 50 and ≤ 89 years of age with a diagnosis of active subfoveal CNV secondary to wAMD in the Study Eye
• 2. BCVA between 20/40 and 20/400 in the Study Eye, with BCVA decrement primarily attributable to wAMD
• 3. Administration of at least 3 anti-VEGF 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).
• 4. Must be pseudo phakic (status post cataract surgery) in the Study Eye
• 5. 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.
• 6. 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)
• 7. 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
• 8. Willingness and ability to comply with schedule for follow-up visits and postoperative evaluations
• 1. CNV or macular edema in the Study Eye secondary to any causes other than AMD
• 2. Any condition preventing visual acuity improvement in the Study Eye, e.g., fibrosis, atrophy, or retinal pigment epithelial tear involving the center of the macula
• 3. Any ophthalmic condition that precludes adequate ophthalmic examination or requires treatment
• 4. Retinal detachment or history of retinal detachment in the Study Eye
• 5. 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
• 6. 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
• 7. History of vitrectomy, trabeculectomy, glaucoma tube-shunt procedure, minimally invasive glaucoma surgery (MIGS) device, or other filtration surgery in the Study Eye
• 8. Photodynamic therapy or retinal laser for the treatment of wAMD within the last 6 months
• 9. 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
• 10. Any previous intraocular or refractive surgery on the Study Eye within 6 months
• 11. Any previous gene therapy in the Study Eye
• 12. Presence of an ocular implant in the Study Eye at Screening, excluding intraocular lens and custom flex iris prosthesis
• 13. 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
• 14. Medically uncontrolled diabetes, defined as HbA1C \> 8.0
• 15. History of ocular melanoma
• 16. History of any known inherited retinal disease
• 17. 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
• 18. Any underlying systemic diseases as unstable or severe cardiovascular, cerebrovascular, dementia or neurodegenerative diseases of a level that prevents adequate evaluation of the subject during the study, active malignancy or currently undergoing treatment for active malignancy at Screening or a history of malignancy that precludes completion of this 260 week study, and immunocompromised conditions and/or need for immunosuppressive therapy
• 19. Active hepatitis B or C
• 20. History of human immunodeficiency virus (HIV), active tuberculosis, and/or syphilis
• 21. Any significant illness that would preclude study compliance and follow-up
• 22. Subjects who, in the Investigator's opinion, lack the mental capacity to provide written informed consent for study participation