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Recruiting Phase 3

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

NCT07453888 · tracked via the Priya Life Science UK tracker
Phase
Phase 3
Started
2026-07-01
Last updated
2026-10-27

Condition(s) studied

Non-Arteritic Anterior Ischemic Optic Neuropathy

Investigational drug(s) / intervention(s)

Cenegermin →Vehicle

Cenegermin: Cenegermin is administered intranasally.

Vehicle: Vehicle spray is administered intranasally.

Study 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

Sex
ALL
Min age
50 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Achievement of ≥ 15 letter increase in Best Corrected Visual Acuity (BCVA), assessed in each individual participant, measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart — Baseline to Week 24
    Improvement in visual acuity defined as a \>=15 letter increase in BCVA using ETDRS chart.

Trial sites (38)

FacilityCityRegionStatus
Neuro Eye Orbit Institute Los Angeles California Recruiting
David Geffen School of Medicine at UCLA - Ophthalmology Los Angeles California Not Yet Recruiting
California Orbital Consultants Newport Beach California Recruiting
Stanford Byers Eye Institute Palo Alto California Recruiting
UC Davis Health, Ophthalmology Sacramento California Recruiting
University of Colorado Anschutz Medical Campus Aurora Colorado Recruiting
Bascom Palmer Eye Institute, University of Miami School of Medicine Miami Florida Not Yet Recruiting
Sarasota Retina Institute - Research Sarasota Florida Recruiting
University of South Florida/Ophthalmology Tampa Florida Recruiting
Emory University - Emory Eye Center - Atlanta Atlanta Georgia Recruiting
Northwestern University - Ophthalmology Chicago Illinois Recruiting
University of Illinois at Chicago Eye and Ear Infirmary - Ophthalmology Chicago Illinois Recruiting
Univ. Of Kentucky Clinic Dept of Ophthalmology & Vision Science Lexington Kentucky Not Yet Recruiting
The Johns Hopkins Hospital (JHH) Baltimore Maryland Recruiting
Tufts Medical Center - Neurology Boston Massachusetts Recruiting
University of Michigan Health - Kellogg Eye Center Ann Arbor Michigan Recruiting
Trinity Health Grand Rapids Grand Rapids Michigan Recruiting
University of Minnesota, Dept of Ophthalmology Minneapolis Minnesota Recruiting
Mayo Clinic - Department of Ophthalmology Rochester Minnesota Recruiting
Washington University School of Medicine in St Louis - Ophthalmology St Louis Missouri Recruiting
UNMC Truhlsen Eye Institute Omaha Nebraska Recruiting
Duke Eye Center - Ophthalmology Durham North Carolina Recruiting
University of Pennsylvania - Ophthalmology Philadelphia Pennsylvania Recruiting
Wills Eye Hospital Philadelphia Pennsylvania Not Yet Recruiting
Retina Consultants of South Carolina, Charleston Neuroscience Institute- West Ashley (RCA) Charleston South Carolina Recruiting
Neuro Eye Clinical Trials Houston Texas Recruiting
Retina Consultants of Texas - The Woodlands The Woodlands Texas Recruiting
Vision SA - Ophthalmology Kent Town South Australia Recruiting
Cerulea East Melbourne Victoria Recruiting
Pusan National University Hospital - Ophthalmology Busan Busan Gwang'yeogsi Recruiting
Asan Medical Center - Ophthalmology Seoul Seoul Teugbyeolsi Recruiting
Samsung Medical Center - Ophthalmology Seoul Seoul Teugbyeolsi Recruiting
Western Eye Hospital London Greater London Recruiting
Manchester University NHS Foundation Trust - Manchester Royal Eye Hospital Manchester Greater Manchester Recruiting
Oxford University Hospital NHS Trust - John Radcliffe Hospital Abingdon Oxfordshire Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital York Sheffield Recruiting
Bristol NHS Foundation Trust - Bristol Eye Hospital Bristol United Kingdom Recruiting
Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital - St Paul's Eye Unit Liverpool United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07453888 on ClinicalTrials.gov ↗ ← All trials in the UK