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RecruitingPhase 3

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

Dompé Farmaceutici S.p.A · NCT07453888

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 50–80 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
272
US sites recruiting
14
Study start
July 1, 2026
Record last updated
September 10, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: Cenegermin; Vehicle

Conditions: Non-Arteritic Anterior Ischemic Optic Neuropathy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Key Inclusion Criteria

  • 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.

Key Exclusion Criteria

  • 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.
  • Abnormal laboratory findings suggestive of temporal arteritis (giant cell arteritis), in the absence of a known acute cause
  • 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.

Note: Additional inclusion/exclusion criteria apply, as defined in the protocol.

Recruiting US locations

  • Neuro Eye Orbit Institute

    Los Angeles, CA 90048

    Site contact: 310-469-9080 · sbose@neuroeyeorbit.com

  • California Orbital Consultants

    Newport Beach, CA 92660

    Site contact: 626-475-0989 · Madhu.agarwal@nvisioncenters.com

  • University of Colorado Anschutz Medical Campus

    Aurora, CO 80045

    Site contact: 303-724-9008 · prem.subramanian@ucdenver.edu

  • Sarasota Retina Institute - Research

    Sarasota, FL 34239

    Site contact: 941-921-5335 · sri30research@aol.com

  • Emory University - Emory Eye Center - Atlanta

    Atlanta, GA 30322

    Site contact: 404-778-2020 · michael.dattilo@emory.edu

  • Tufts Medical Center - Neurology

    Boston, MA 02116

    Site contact: 617-636-5489 · Laurel.Vuong@tuftsmedicine.org

  • University of Michigan Health - Kellogg Eye Center

    Ann Arbor, MI 48105

    Site contact: 734-763-0482 · ldelott@med.umich.edu

  • Trinity Health Grand Rapids

    Grand Rapids, MI 49503

    Site contact: 616-685-6306 · santosro@trinity-health.org

  • Mayo Clinic - Department of Ophthalmology

    Rochester, MN 55905

    Site contact: 480-574-1160 · chen.john@mayo.edu

  • Washington University School of Medicine in St Louis - Ophthalmology

    St Louis, MO 63108

    Site contact: 314-286-2946 · vanstaverng@wustl.edu

  • Duke Eye Center - Ophthalmology

    Durham, NC 27705

    Site contact: 919-668-0558 · sid.gospe@duke.edu

  • University of Pennsylvania - Ophthalmology

    Philadelphia, PA 19104

    Site contact: 215-662-8696 · madhura.tamhankar@pennmedicine.upenn.edu

  • Retina Consultants of South Carolina, Charleston Neuroscience Institute- West Ashley (RCA)

    Charleston, SC 29414

    Site contact: 843-763-4466 · john.kerrison@retinasouthcarolina.com

  • Neuro Eye Clinical Trials

    Houston, TX 77074

    Site contact: 346-429-4135 · rosatang.md@me.com

Study contacts (from the official record)

  • Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI) · +39 02 583 831
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Efficacy and Safety of Intranasal Cenegermin in Adult Participants… (NCT07453888) | Bored Studies