drugset / Trial / NCT07453888

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

NCT07453888 ↗

Phase 3 Recruiting 272 enrolled Dompé Farmaceutici S.p.A
RandomizedParallel-groupTriple-blindTreatment

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).

Timeline

Start
2026-07-01
Primary completion
2027-09
Completion
2027-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Cenegermin Protein / enzyme biologic — Intranasal