Clinical Trial

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

Recruiting Phase 3
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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).
Protocol Amendment History 2 changes
critical Recruitment opened 2026-06-23
notable Trial sites expanded: 0 -> 18 locations 2026-06-23
Trial Details
NCT Number NCT07453888
Lead Sponsor Dompé Farmaceutici S.p.A
Conditions Non-Arteritic Anterior Ischemic Optic Neuropathy
Enrollment 272 participants
Start Date 2026-07-01
Primary Completion 2027-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-15