Intranasal cenegermin for NAION in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3, randomized, multicenter, double-masked trial comparing intranasal cenegermin to vehicle in adults with unilateral NAION. About 272 participants will be assigned 1:1 to receive either cenegermin or vehicle, to assess safety and efficacy. Eligible participants have recent NAION onset within 14 days, a measurable visual acuity range, and adequate ocular clarity for examinations. Key exclusions include bilateral involvement, signs of temporal arteritis, high IOP or glaucoma in the study eye, and certain AMD conditions. The study is led by Dompé Farmaceutici with multiple ophthalmology centers in California.

Why it matters

Who can join: the full rules

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.

Where it's running

• Neuro Eye Orbit Institute
  Los Angeles, California, United States Recruiting
• California Orbital Consultants
  Newport Beach, California, United States Recruiting
• Stanford Byers Eye Institute
  Palo Alto, California, United States Recruiting
• UC Davis Health, Ophthalmology
  Sacramento, California, United States Recruiting
• University of Colorado Anschutz Medical Campus
  Aurora, Colorado, United States Recruiting
• Sarasota Retina Institute - Research
  Sarasota, Florida, United States Recruiting

Study contacts

• Study coordinator: Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)
• Phone: +39 02 583 831

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.