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NCT Number: NCT07453888

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

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).

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Key information

Conditions

Non-Arteritic Anterior Ischemic Optic Neuropathy Cardiovascular Diseases Cranial Nerve Diseases Eye Diseases Nervous System Diseases Optic Nerve Diseases Optic Neuropathy, Ischemic Vascular Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

David Geffen School of Medicine at UCLA - Ophthalmology, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.

Note: Additional inclusion/exclusion criteria apply, as defined in the protocol.

Treatment and study plan

Cenegermin

Drug

Cenegermin is administered intranasally.

Vehicle

Other

Vehicle spray is administered intranasally.

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

    Time frame: Baseline to Week 24

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

Secondary outcomes

  1. Change from baseline in visual field mean sensitivity in decibels

    Time frame: Baseline through Week 24

    Change from baseline in visual field mean sensitivity in decibels will be analyzed

  2. Change from baseline in BCVA as measured by the ETDRS chart

    Time frame: Baseline through Week 24

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

    Time frame: Baseline through Week 24

    Change from baseline in mean sensitivity at week 24 in loci prespecified at baseline will be analyzed.

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

    Time frame: Baseline through Week 24

    Change from baseline in GCL-IPL thickness on optical coherence tomography will be analyzed.

  5. Incidence of ocular and non-ocular adverse events

    Time frame: Through Week 24

    Number of participants with ocular and non-ocular adverse events will be assessed.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

+39 02 583 831

Sponsors and collaborators

Lead sponsor

Dompé Farmaceutici S.p.A

Industry

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 6, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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