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

NCT07453888 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2026-07-15

No results posted yet for this study

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

DRUG

Cenegermin

Cenegermin is administered intranasally.

OTHER

Vehicle

Vehicle spray is administered intranasally.

Sponsors & Collaborators

  • Dompé Farmaceutici S.p.A

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07453888 on ClinicalTrials.gov