Efficacy and Safety Study of iSONEP With & Without Lucentis/Avastin/Eylea to Treat Wet AMD

Exclusion Criteria

• •Most recent IVT injection of Lucentis or Avastin fewer than 28 days and more than 65 days prior to screening
• •Most recent IVT injection of Eylea fewer than 42 days and more than 79 days prior to screening
• •Previous photodynamic therapy (PDT) or Macugen® at any time point
• •Focal thermal laser or grid laser within 3 months prior to Day 0
• •Use of IVT, subtenon or subconjunctival steroids within 3 months prior to Day 0
• •Use of topical ophthalmic corticosteroids 2 weeks prior to Day 0
• •Intraocular surgery, including cataract surgery, and / or laser of any type within 3 months prior to Day 0 or anticipated need for ocular surgery or ophthalmic laser treatment during the study period
• •Subjects previously treated with, or are currently receiving treatment with another investigational agent or device for neovascular AMD in the study eye
• •Retinal total lesion size \>12 disc areas (30.5 mm2), including blood, scars and neovascularization as assessed by FA in the study eye
• •Presence of a fibrovascular PED extending underneath the center of the fovea
• •Presence of retinal angiomatous proliferation (RAP) lesions
• •Presence of polypoidal choroidal vasculopathy (PCV) (if suspected, Indocyanine Green Angiography (ICG) should be performed at the discretion of the Investigator)
• •Subretinal hemorrhage in the study eye if any of the following is true: (i) the subretinal hemorrhage represents 50% or more of the total lesion area; (ii) subfoveal blood is 1 or more disc areas in size (iii) subfoveal blood where the fovea is surrounded by less than 270 degrees of visible CNV on FA
• •Scar or fibrosis making up \>50% of total lesion area in the study eye
• •Anatomic damage to the center of the fovea including fibrosis, scarring or atrophy
• •History of a retinal pigment epithelial tear
• •History of vitreous hemorrhage within 4 weeks prior to screening in the study eye
• •Clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina, other than AMD, in either eye
• •Uncontrolled glaucoma defined as: (i) as intraocular pressure ≥25 mmHg despite treatment with anti glaucoma medication in the study eye or (ii) by the Investigator
• •Prior trabeculectomy or other filtration surgery in the study eye (prior laser trabeculoplasty is allowed)