Age-related Macular Degeneration // Clinical Trials // Mihai Mititelu // Ongoing // Sep 30 2020
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
Study objective:
To examine the safety and effectiveness of ONS-5010 in participants with neovascular age-related macular degeneration as compared with ranibizumab.
Study design:
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.
Inclusion criteria:
- 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
Exclusion criteria:
- 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)
Contact Nickie Stangel with questions: 608-263-8783. For more information about this study: visit clinicaltrials.gov