A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)

Prior treatment

• Previous subfoveal focal laser photocoagulation in the study eye
• Any concurrent intraocular condition in the study eye that may require medical or surgical intervention or contribute to vision loss within 1 year
• Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)

Other illness

• Current vitreous hemorrhage in the study eye
• History of idiopathic or autoimmune-associated uveitis in either eye
• Current treatment for active systemic infection
• Known allergy to any component of the study drug or history of allergy to fluorescein , not amenable to treatment

Other

• Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1-month preceding randomization
• Active intraocular inflammation (grade trace or above) in the study eye
• Polypoidal choroidal vasculopathy (PCV) in the study eye
• Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
• Premenopausal women not using adequate contraception

• Active primary Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye
• Best corrected visual acuity of 35-75 letters read (20/32 to 20/200 Snellen equivalent)
• Study eye must:
• Have active leakage on Fluorescein Angiogram involving the fovea
• Have edema involving the fovea
• Be free of scarring, fibrosis, or atrophy involving the central foveal zone