NORSE

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