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NOT YET RECRUITING
NCT07453888
PHASE3

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

Sponsor: Dompé Farmaceutici S.p.A

View on ClinicalTrials.gov

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).

Official title: 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)

Key Details

Gender

All

Age Range

50 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

272

Start Date

2026-03

Completion Date

2027-09

Last Updated

2026-03-06

Healthy Volunteers

No

Interventions

DRUG

Cenegermin

Cenegermin is administered intranasally.

OTHER

Vehicle

Vehicle spray is administered intranasally.