Not Yet RecruitingPhase 3

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

272 participantsStarted 2026-04-30

Plain-language 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).

Who can participate

Age range50 Years – 80 Years

SexALL

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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.

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.

What they're measuring

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

Timeframe: Baseline to Week 24

Trial details

NCT IDNCT07453888

SponsorDompé Farmaceutici S.p.A

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-09

Contact for this trial

Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)

+39 02 583 831

View on ClinicalTrials.gov More Non-Arteritic Anterior Ischemic Optic Neuropathy trials