Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
Recruiting now · Phase 3
Conditions studied: Non-Arteritic Anterior Ischemic Optic Neuropathy
In brief
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).
Key facts
- Study ID
- NCT07453888
- Run by
- Dompé Farmaceutici S.p.A
- People needed
- 272
- Starts
- 2026-07-01
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2026-07-15
Who can join
Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Neuro Eye Orbit Institute — Los Angeles, California, United States (enrolling)
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)
- University of Michigan Health - Kellogg Eye Center — Ann Arbor, Michigan, United States (enrolling)
- Mayo Clinic - Department of Ophthalmology — Rochester, Minnesota, United States (enrolling)
- University of Pennsylvania - Ophthalmology — Philadelphia, Pennsylvania, United States (enrolling)
- Retina Consultants of South Carolina, Charleston Neuroscience Institute- West Ashley (RCA) — Charleston, South Carolina, United States (enrolling)
- Neuro Eye Clinical Trials — Houston, Texas, United States (enrolling)
- 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 Minnesota, Dept of Ophthalmology — Minneapolis, Minnesota, United States
- David Geffen School of Medicine at UCLA - Ophthalmology — Los Angeles, California, United States
- California Orbital Consultants — Newport Beach, California, United States
- Trinity Health Grand Rapids — Grand Rapids, Michigan, 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
Full record on ClinicalTrials.gov
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