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

This is an interventional treatment trial for Exudative Age-related Macular Degeneration focused on measuring choroidal neovascularization, age-related macular degeneration, iSONEP, sonepcizumab, Lucentis, ranibizumab, Avastin, bevacizumab, Eylea, aflibercept Read More

Inclusion Criteria:

• ≥50 years of age with a diagnosis of wet AMD
• Subjects who have received 3 injections of Lucentis or Avastin or Eylea within 12 months prior to screening
• Active subfoveal CNV secondary to AMD (leakage on FA)
• Presence of residual subretinal or intraretinal fluid on Cirrus or Spectralis SDOCT
• SDOCT in the 1 mm central macular subfield on the retinal map analysis of ≥250 μm at screening
• ETDRS BCVA of ≥25 and ≤73 letters (approximately 20/320 and 20/40 on the Snellen scale) at screening and on Day 0
• In the fellow eye, ETDRS BCVA of 20/400 or better
• Subject with serous pigment epithelial detachment (PED) (any part of which may be subfoveal) with intraretinal and/or subretinal fluid may be included

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)