Treatment of Advanced Dry Age Related Macular Degeneration With AAVCAGsCD59

Exclusion Criteria

• •GA secondary to non AMD etiologies
• •Prior or active choroidal neovascularization (CNV) in the study eye
• •History of conditions in the study eye during screening which might alter visual acuity or interfere with study testing
• •Active uncontrolled glaucoma
• •Intraocular surgery in the study eye within 3 months of enrollment or are known or likely candidate for intraocular surgery (including cataract surgery) in the study eye within 1 year of treatment
• •Acute or chronic infection in the study eye
• •History of inflammation in the study eye or ongoing inflammation in either eye
• •History of uveitis in the study eye
• •Ongoing ocular inflammation in either eye
• •Any contraindication to intravitreal injection
• •Currently using or have used treatment for exudative AMD in the study eye only: laser photocoagulation, photodynamic therapy (PDT), ranibizumab (Lucentis®), pegaptanib sodium (Macugen®), bevacizumab (Avastin®) or aflibercept (Eylea®)
• •Currently using any periocular (study eye), intravitreal (study eye) or systemic (oral or intravenous) corticosteroids within 3 months prior to screening.
• •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;
• •* Poorly controlled diabetes;
• •* Clinically significant impaired renal or hepatic function, for example:
• •* Cerebrovascular disease within 12 months prior to Screening;
• •* Dementia or neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease);
• •* Have a malignancy at Screening or a history of malignancy that precludes completion of this 2-year study, including presence of tumor or disease whose treatment may directly affect the ability to evaluate the safety and efficacy of AAVCAGsCD59, or currently undergoing treatment for a specific cancer;
• •* Immunocompromised conditions and/or need for immunosuppressive therapy;
• •Any significant poorly controlled illness that would preclude study compliance and follow-up
• •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
• •Previous treatment with any ocular or systemic gene transfer product
• •Received any investigational product within 120 days prior to screening