AAVCAGsCD59 for the Treatment of Wet AMD

Exclusion Criteria

• •1. Wet AMD secondary to non-AMD etiologies.
• •2. Subretinal hemorrhage that interferes with the ability to adequately measure visual acuity or follow retinal or subretinal fluid collection on OCT.
• •3. Serous pigment epithelial detachment (PED) that is \>50% of the CNV lesion, \>400µm in any diameter, or presence of a RPE tear.
• •4. Presence of polypoidal choroidal vasculopathy (PCV), retinal angiomatous proliferation (RAP), central serous retinopathy, or symptomatic vitreomacular adhesion.
• •5. Previous macular laser photocoagulation for CNV, photodynamic therapy (PDT), ocular radiation, or subretinal surgery for CNV in the study eye.
• •6. History of conditions in the study eye which might alter visual acuity or interfere with study testing including clinically significant macular edema, central retinal vein occlusion, macular branch retinal vein occlusion, and optic neuropathy.
• •7. Active uncontrolled glaucoma with IOP\>30 mmHg despite treatment with glaucoma medications, cup-to-disc ratio of \>0.9, visual field defects secondary to glaucoma that involve the macula, and optic atrophy from glaucoma.
• •8. Likely candidate for intraocular surgery (including cataract surgery) in the study eye during the clinical trial.
• •9. Acute or chronic infection in the study eye.
• •10. History of uveitis unrelated to eye surgery in the study eye or opposite eye requiring treatment with topical corticosteroids or systemic immunosuppression within 24 months of enrollment.
• •11. Any contraindication to intravitreal injection.
• •12. Use intravitreal (study eye) corticosteroids within 3 months prior to screening.
• •13. Any of the following underlying systemic diseases:
• •* Unstable or severe cardiovascular disease, e.g., congestive heart failure (New York Heart Association Functional class III or IV), myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina, or critical limb ischemia;
• •* Cerebrovascular disease within 12 months prior to Screening that impairs the patient's ability to participate in the clinical trial;
• •* Dementia or neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease) of a level that prevents adequate evaluation of the subject during the study;
• •* Has an active malignancy or is currently undergoing treatment for an active malignancy at Screening, or has a history of malignancy that precludes completion of this 12-month study;
• •* Immunocompromised conditions and/or need for immunosuppressive therapy
• •14. Any significant poorly controlled illness that would preclude study compliance and follow-up
• •15. Current or prior use of any medication known to be toxic to the retina or optic nerve including, but not limited, to chloroquine/hydrochloroquine, deferoxamine, phenothiazines and ethambutol
• •16. Previous treatment with any ocular or systemic gene transfer product
• •17. Received any investigational product within 120 days prior to screening
• •18. Any psychological, familial, sociological, geographical, or other condition that would preclude study compliance and follow-up