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NCT07453888PHASE3Recruiting

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

Dompé Farmaceutici S.p.A

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

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.

Interventions

DRUG

Cenegermin

OTHER

Vehicle

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Conditions

Non-Arteritic Anterior Ischemic Optic Neuropathy

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