Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
Start Date
7/1/2026
Completion Date
9/1/2027
Summary
This is a phase 3, randomized, multicenter, vehicle-controlled, double-masked study to evaluate the efficacy and safety of intranasal cenegermin compared with vehicle control in adult participants with NAION. Approximately 272 participants who meet all eligibility criteria will be randomly assigned in a 1:1 ratio to receive either cenegermin treatment (Group 1) or the vehicle control (Group 2).
Eligibility Criteria
Age Range: 50 years to 80 years
Interventions
Cenegermin
Vehicle
Conditions
Locations
Neuro Eye Orbit Institute
Los Angeles, California 90048
United States
David Geffen School of Medicine at UCLA - Ophthalmology
Los Angeles, California 90095
United States
California Orbital Consultants
Newport Beach, California 92660
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
United States
Bascom Palmer Eye Institute, University of Miami School of Medicine
Miami, Florida 33136
United States
Sarasota Retina Institute - Research
Sarasota, Florida 34239
United States
Northwestern University - Ophthalmology
Chicago, Illinois 60611
United States
University of Illinois at Chicago Eye and Ear Infirmary - Ophthalmology
Chicago, Illinois 60612
United States
Univ. Of Kentucky Clinic Dept of Ophthalmology & Vision Science
Lexington, Kentucky 40508
United States
The Johns Hopkins Hospital (JHH)
Baltimore, Maryland 21287
United States
Tufts Medical Center - Neurology
Boston, Massachusetts 02116
United States
University of Michigan Health - Kellogg Eye Center
Ann Arbor, Michigan 48105
United States
Trinity Health Grand Rapids
Grand Rapids, Michigan 49503
United States
University of Minnesota, Dept of Ophthalmology
Minneapolis, Minnesota 55455
United States
Mayo Clinic - Department of Ophthalmology
Rochester, Minnesota 55905
United States
University of Pennsylvania - Ophthalmology
Philadelphia, Pennsylvania 19104
United States
Retina Consultants of South Carolina, Charleston Neuroscience Institute- West Ashley (RCA)
Charleston, South Carolina 29414
United States
Neuro Eye Clinical Trials
Houston, Texas 77074
United States