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Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
Sponsor: Dompé Farmaceutici S.p.A
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).
Official title: Randomized, Multicenter, Vehicle-Controlled, Double-Masked Phase 3 Study to Evaluate the Efficacy and Safety of Intranasal Cenegermin (Recombinant Human Nerve Growth Factor [rhNGF]) in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
Key Details
Gender
All
Age Range
50 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
272
Start Date
2026-06-30
Completion Date
2027-09
Last Updated
2026-06-22
Healthy Volunteers
No
Interventions
Cenegermin
Cenegermin is administered intranasally.
Vehicle
Vehicle spray is administered intranasally.
Locations (18)
Neuro Eye Orbit Institute
Los Angeles, California, United States
David Geffen School of Medicine at UCLA - Ophthalmology
Los Angeles, California, United States
California Orbital Consultants
Newport Beach, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Bascom Palmer Eye Institute, University of Miami School of Medicine
Miami, Florida, United States
Sarasota Retina Institute - Research
Sarasota, Florida, United States
Northwestern University - Ophthalmology
Chicago, Illinois, United States
University of Illinois at Chicago Eye and Ear Infirmary - Ophthalmology
Chicago, Illinois, United States
Univ. Of Kentucky Clinic Dept of Ophthalmology & Vision Science
Lexington, Kentucky, United States
The Johns Hopkins Hospital (JHH)
Baltimore, Maryland, United States
Tufts Medical Center - Neurology
Boston, Massachusetts, United States
University of Michigan Health - Kellogg Eye Center
Ann Arbor, Michigan, United States
Trinity Health Grand Rapids
Grand Rapids, Michigan, United States
University of Minnesota, Dept of Ophthalmology
Minneapolis, Minnesota, United States
Mayo Clinic - Department of Ophthalmology
Rochester, Minnesota, United States
University of Pennsylvania - Ophthalmology
Philadelphia, Pennsylvania, United States
Retina Consultants of South Carolina, Charleston Neuroscience Institute- West Ashley (RCA)
Charleston, South Carolina, United States
Neuro Eye Clinical Trials
Houston, Texas, United States