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

Korábbi kezelés

• 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
• Photodynamic therapy or retinal laser for the treatment of wAMD within the last 6 months
• 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
• 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

Más betegség

• 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
• Any ophthalmic condition that precludes adequate ophthalmic examination or requires treatment
• Retinal detachment or history of retinal detachment in the Study Eye
• History of vitrectomy, trabeculectomy, glaucoma tube-shunt procedure, minimally invasive glaucoma surgery (MIGS) device, or other filtration surgery in the Study Eye
• 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
• History of ocular melanoma
• History of any known inherited retinal disease
• 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
• 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

Laborértékek

• Medically uncontrolled diabetes, defined as HbA1C > 8.0

Egyéb

• CNV or macular edema in the Study Eye secondary to any causes other than AMD
• Subjects who, in the Investigator's opinion, lack the mental capacity to provide written informed consent for study participation

• 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