Efficacy and Safety of Squalamine Lactate Eye Drops in Subjects With Neovascular (Wet) Age-related Macular Degeneration (AMD)

Exclusion Criteria

• •Neovascularization secondary to any condition other than AMD in the study eye.
• •Blood occupying greater than 50% of the AMD lesion. Blood underlying the fovea.
• •Prior treatment in the study eye with bevacizumab, ranibizumab, aflibercept, PDT, submacular surgery, any antiangiogenic drug.
• •Confounding ocular conditions in the study eye which will affect interpretation of OCT, VA or assessment of macular appearance eg: cataract.
• •Subjects with VA worse than 20/200 (less than 34 letters) in the fellow (non-study) eye.
• •Fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study eye or any condition preventing VA improvement.
• •Prior ocular surgery in the study eye (Vitrectomy, scleral buckle, or glaucoma filter/shunt). Cataract surgery more than 3 months prior to enrollment is allowed so long as a posterior chamber intraocular lens is in place.
• •Wearing contact lenses.
• •Concomitant therapy with any drug that may affect VA, meds that may be toxic to the lens/retina or optic nerve.
• •Current ocular or periocular infection in the study eye.
• •Hypersensitivity to Lucentis.
• •Hypersensitivity to squalamine or any component of the ophthalmic formulation
• •Presence of a life threatening disease or currently on treatment for a malignancy.
• •Currently on chemotherapy.
• •Currently on systemic steroids.
• •Pregnant or lactating.
• •Investigational product use of any kind in the previous 30 days.
• •Subjects for whom attendance for monthly examinations may be unreliable eg: dependent on an elderly caregiver.
• •Glaucoma in the study eye (glaucomatous visual field defect and receiving treatment).
• •Myocardial infarction or cerebrovascular accident or transient ischemic attacks (TIA) within the past 6 months.
• •Clinical evidence of diabetic retinopathy or diabetic macular edema in the study eye.
• •Uncontrolled hypertension (Diastolic BP \>105 mmHg) in spite of antihypertensive medications.
• •Subjects known to have HIV.
• •A history of drug or alcohol abuse.
• •Subjects unable to administer eye drops reliably.