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RECRUITING Phase 3 ClinicalTrials.gov

Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)

Sponsor: Dompé Farmaceutici S.p.A • ClinicalTrials.gov ID: NCT07453888

Registry updated: 2026-09-10
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Description

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).

Interventions

  • Cenegermin (Drug)
    Cenegermin is administered intranasally.
  • Vehicle (Other)
    Vehicle spray is administered intranasally.

Eligibility criteria

Key Inclusion Criteria: 1. A clinical diagnosis of unilateral NAION in the study eye with symptom onset within 14 days prior to the planned date for first dose administration. 2. A BCVA score in the study eye of ≥ 15 letters and ≤ 65 letters measured using the ETDRS chart. 3. Sufficiently clear ocular media and adequate pupil dilation to enable assessment of the optic nerve and retina in both eyes. Key Exclusion Criteria: 1. Bilateral NAION or sequential NAION with fellow eye involvement within 6 weeks of study eye involvement. 2. Clinical evidence of temporal arteritis (giant cell arteritis) signs or symptoms. 3. Abnormal laboratory findings suggestive of temporal arteritis (giant cell arteritis), in the absence of a known acute cause 4. Pain with eye movement 5. Intraocular pressure (IOP) greater than 25 mmHg in the study eye or history of glaucoma in the study eye. 6. Intermediate age-related macular degeneration (AMD) with subfoveal drusen, exudative AMD, or geographic atrophy in the study eye. Note: Additional inclusion/exclusion criteria apply, as defined in the protocol.

Conditions

Non-Arteritic Anterior Ischemic Optic Neuropathy

Locations

  • 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
  • Emory University - Emory Eye Center - Atlanta — Atlanta, Georgia, 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
  • Washington University School of Medicine in St Louis - Ophthalmology — St Louis, Missouri, United States
  • Duke Eye Center - Ophthalmology — Durham, North Carolina, United States
  • University of Pennsylvania - Ophthalmology — Philadelphia, Pennsylvania, United States
  • Wills Eye Hospital — 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
  • Vision SA - Ophthalmology — Kent Town, South Australia, Australia
  • Western Eye Hospital — London, Greater London, United Kingdom
  • Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital - St Paul's Eye Unit — Liverpool, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record