NCT07453888

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

Randomized, Multicenter, Vehicle-Controlled, Double-Masked Phase 3 Study to Evaluate the Efficacy and Safety of Intranasal Cenegermin (Recombinant Human Nerve Growth Factor [rhNGF]) in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 272 (estimated)
• Sponsor: Dompé Farmaceutici S.p.A · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Non-Arteritic Anterior Ischemic Optic Neuropathy

Interventions

Type	Name	Description
DRUG	Cenegermin	Cenegermin is administered intranasally.
OTHER	Vehicle	Vehicle spray is administered intranasally.

Timeline

• Start date: 2026-04-30
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2026-03-06
• Last updated: 2026-04-20

Regulatory

• FDA-regulated drug study
• FDA-regulated device study