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Clinical Trials in the UK / NCT07453888
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
Sponsor
Dompé Farmaceutici S.p.A
Phase
Phase 3
Started
2026-07-01
Last updated
2026-09-10

Condition(s) studied

Non-Arteritic Anterior Ischemic Optic Neuropathy

Investigational drug(s) / intervention(s)

CenegerminVehicle

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)

Trial sites (25)

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
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
Emory University - Emory Eye Center - Atlanta Atlanta Georgia Recruiting
Northwestern University - Ophthalmology Chicago Illinois Not Yet Recruiting
University of Illinois at Chicago Eye and Ear Infirmary - Ophthalmology Chicago Illinois Not Yet Recruiting
Univ. Of Kentucky Clinic Dept of Ophthalmology & Vision Science Lexington Kentucky Not Yet Recruiting
The Johns Hopkins Hospital (JHH) Baltimore Maryland Not Yet 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 Not Yet Recruiting
Mayo Clinic - Department of Ophthalmology Rochester Minnesota Recruiting
Washington University School of Medicine in St Louis - Ophthalmology St Louis Missouri 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
Vision SA - Ophthalmology Kent Town South Australia Recruiting
Western Eye Hospital London Greater London Recruiting
Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital - St Paul's Eye Unit Liverpool United Kingdom Recruiting

More Dompé Farmaceutici S.p.A trials in the UK

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