NCT07453888

Brief 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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
272

participants targeted

Target at P50-P75 for phase_3

Timeline
15mo left

Started Apr 2026

Shorter than P25 for phase_3

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Sep 2027

First Submitted

Initial submission to the registry

March 2, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 30, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

March 2, 2026

Last Update Submit

April 16, 2026

Conditions

Non-Arteritic Anterior Ischemic Optic Neuropathy

Keywords

Acute optic neuropathyNon-Arteritic Anterior Ischemic Optic NeuropathyNAIONcenegerminOptic neuropathyIntranasal

Outcome Measures

Primary Outcomes (1)

  • Achievement of ≥ 15 letter increase in Best Corrected Visual Acuity (BCVA), assessed in each individual participant, measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart

    Improvement in visual acuity defined as a \>=15 letter increase in BCVA using ETDRS chart.

    Baseline to Week 24

Secondary Outcomes (5)

  • Change from baseline in visual field mean sensitivity in decibels

    Baseline through Week 24

  • Change from baseline in BCVA as measured by the ETDRS chart

    Baseline through Week 24

  • Change from baseline in visual field mean sensitivity, in a prespecified region consisting of at least 5 separate loci on visual field testing

    Baseline through Week 24

  • Change from baseline in ganglion cell layer-inner plexiform layer (GCL-IPL) thickness (micrometer [μm]) on optical coherence tomography (OCT).

    Baseline through Week 24

  • Incidence of ocular and non-ocular adverse events

    Through Week 24

Study Arms (2)

Cenegermin

EXPERIMENTAL

Participants will be administered with cenegermin spray in each nostril.

Drug: Cenegermin

Vehicle

PLACEBO COMPARATOR

Participants will be administered with vehicle spray in each nostril.

Other: Vehicle

Interventions

CenegerminDRUG

Cenegermin is administered intranasally.

Cenegermin
VehicleOTHER

Vehicle spray is administered intranasally.

Vehicle

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A clinical diagnosis of unilateral NAION in the study eye with symptom onset within 14 days prior to the planned date for first dose administration.
  • A BCVA score in the study eye of ≥ 15 letters and ≤ 65 letters measured using the ETDRS chart.
  • Sufficiently clear ocular media and adequate pupil dilation to enable assessment of the optic nerve and retina in both eyes.

You may not qualify if:

  • Bilateral NAION or sequential NAION with fellow eye involvement within 6 weeks of study eye involvement.
  • Clinical evidence of temporal arteritis (giant cell arteritis) signs or symptoms.
  • Abnormal laboratory findings suggestive of temporal arteritis (giant cell arteritis), in the absence of a known acute cause
  • Pain with eye movement
  • Intraocular pressure (IOP) greater than 25 mmHg in the study eye or history of glaucoma in the study eye.
  • Intermediate age-related macular degeneration (AMD) with subfoveal drusen, exudative AMD, or geographic atrophy in the study eye.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Optic Neuropathy, IschemicOptic Nerve Diseases

Interventions

cenegermin

Condition Hierarchy (Ancestors)

Cranial Nerve DiseasesNervous System DiseasesEye DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)

CONTACT

+39 02 583 831

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The sponsor is also masked to the study treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2026

First Posted

March 6, 2026

Study Start

April 30, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share