RecruitingPhase 3NCT07453888

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

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)

Sponsor

Dompé Farmaceutici S.p.A

Enrollment

272 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

Non-arteritic Anterior Ischemic Optic Neuropathy

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

Min Age: 50 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cenegermin and Vehicle for people with non-arteritic anterior ischemic optic neuropathy. The study is currently recruiting participants at 18 locations. People eligible for this study include aged 50 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCenegermin

Cenegermin is administered intranasally.

OTHERVehicle

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

View Full Details on ClinicalTrials.gov

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NCT07453888