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Accepting PatientsPhase 3 (Comparison)NCT07453888

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

Non-Arteritic Anterior Ischemic Optic Neuropathy

Phase:Phase 3 (Comparison)
Status:Accepting Patients
Age:50 - 80
Gender:All
Locations:25 sites

What This Study Is About

  • Investigates whether intranasal cenegermin improves vision loss in adults with NAION
  • You will receive nasal spray or placebo for several months while being monitored
  • May lead to a new safe treatment that could restore some sight
Technical 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).

Who Can Participate

You May Qualify If
  • 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.
  • A BCVA score in the study eye of ≥ 15 letters and ≤ 65 letters measured using the ETDRS chart.
  • Sufficiently clear ocular media and adequate pupil dilation to enable assessment of the optic nerve and retina in both eyes.
You Cannot Join If
  • Bilateral NAION or sequential NAION with fellow eye involvement within 6 weeks of study eye involvement.
  • Clinical evidence of temporal arteritis (giant cell arteritis) signs or symptoms.
  • Pain with eye movement
  • Intraocular pressure (IOP) greater than 25 mmHg in the study eye or history of glaucoma in the study eye.
  • Intermediate age-related macular degeneration (AMD) with subfoveal drusen, exudative AMD, or geographic atrophy in the study eye.
Discuss With Your Doctor
  • Abnormal laboratory findings suggestive of temporal arteritis (giant cell arteritis), in the absence of a known acute cause
View Full Eligibility Criteria
Full Criteria (from ClinicalTrials.gov)

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.

Important: This is a summary. The final determination of eligibility will be made by the trial coordinator after reviewing your complete medical history.

Study Locations

Neuro Eye Orbit Institute — Los Angeles, California
David Geffen School of Medicine at UCLA - Ophthalmology — Los Angeles, California
California Orbital Consultants — Newport Beach, California
Show all 25 locations
University of Colorado Anschutz Medical Campus — Aurora, Colorado
Bascom Palmer Eye Institute, University of Miami School of Medicine — Miami, Florida
Sarasota Retina Institute - Research — Sarasota, Florida
Emory University - Emory Eye Center - Atlanta — Atlanta, Georgia
Northwestern University - Ophthalmology — Chicago, Illinois
University of Illinois at Chicago Eye and Ear Infirmary - Ophthalmology — Chicago, Illinois
Univ. Of Kentucky Clinic Dept of Ophthalmology & Vision Science — Lexington, Kentucky
The Johns Hopkins Hospital (JHH) — Baltimore, Maryland
Tufts Medical Center - Neurology — Boston, Massachusetts
University of Michigan Health - Kellogg Eye Center — Ann Arbor, Michigan
Trinity Health Grand Rapids — Grand Rapids, Michigan
University of Minnesota, Dept of Ophthalmology — Minneapolis, Minnesota
Mayo Clinic - Department of Ophthalmology — Rochester, Minnesota
Washington University School of Medicine in St Louis - Ophthalmology — St Louis, Missouri
Duke Eye Center - Ophthalmology — Durham, North Carolina
University of Pennsylvania - Ophthalmology — Philadelphia, Pennsylvania
Wills Eye Hospital — Philadelphia, Pennsylvania
Retina Consultants of South Carolina, Charleston Neuroscience Institute- West Ashley (RCA) — Charleston, South Carolina
Neuro Eye Clinical Trials — Houston, Texas
Vision SA - Ophthalmology — Kent Town, South Australia
Western Eye Hospital — London, Greater London
Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital - St Paul's Eye Unit — Liverpool

Contact

Contact

Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)

Experimental Treatment

This trial is testing a new treatment. Results are not guaranteed. Talk to your doctor before applying.

Apply to This Trial

Your information will be sent to the study coordinator for review.