A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects with Neovascular Age-related Macular Degeneration (AMD)
Multicenter, randomized, masked, controlled study of the safety and effectiveness of intravitreally administered ONS-5010.
• Active primary Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye
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• Best corrected visual acuity of 35-75 letters read (20/32 to 20/200 Snellen equivalent)
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• Study eye must:
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• Have active leakage on Fluorescein Angiogram involving the fovea
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• Have edema involving the fovea
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• Be free of scarring, fibrosis, or atrophy involving the central foveal zone
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• Previous subfoveal focal laser photocoagulation in the study eye
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• Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1-month preceding randomization
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• Any concurrent intraocular condition in the study eye that may require medical or surgical intervention or contribute to vision loss within 1 year
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• Active intraocular inflammation (grade trace or above) in the study eye
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• Current vitreous hemorrhage in the study eye
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• Polypoidal choroidal vasculopathy (PCV) in the study eye
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• History of idiopathic or autoimmune-associated uveitis in either eye
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• Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
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• Uncontrolled glaucoma in the study eye (defined as intraocular pressure =30 mmHg despite treatment with anti-glaucoma medication)
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• Premenopausal women not using adequate contraception
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• Current treatment for active systemic infection
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• Known allergy to any component of the study drug or history of allergy to fluorescein , not amenable to treatment
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