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
This study will evaluate the safety, efficacy, and tolerability of ONS-5010 as compared with ranibizumab.
Study participants will be randomized into 2 study groups to receive ONS-5010 or 0.5 mg ranibizumab injections.
Diagnosis and Key Eligibility Criteria:
Male or females ages ≥50 years with active primary subfoveal CNV lesions secondary to AMD in the study eye. Patients receiving anti-VEGF treatment for AMD in the fellow eye are eligible for enrollment in the study. Previous use of anti-VEGF or Avastin in the study eye is not allowed.
Duration of study: Approximately 5 years
For more information, contact Nickie Stangel 608-263-8783