A Clinical Effectiveness, Multicenter, Randomized, Double-masked, Controlled Study of the Efficacy and Safety of ONS-5010 in Subjects with Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD) (NORSE)
Sponsor: Outlook Therapeutics, Inc.
Principal Investigator: Mihai Mititelu, MD, MPH
Study Coordinator: Nickie Stangel
To examine the safety and effectiveness of ONS-5010 in participants with neovascular age-related macular degeneration as compared with ranibizumab.
The duration of the study is approximately 12 months. Subjects will receive intravitreal injections of ONS-5010 once a month or intravitreal injections of ranibizumab administered monthly for 3 doses and then quarterly.
Active primary Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye
Best corrected visual acuity of 25-67 letters read (20/50 to 20/320 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
Previous subfoveal focal laser photocoagulation in the study eye
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
History of idiopathic or autoimmune-associated uveitis in either eye
Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)