NCT07453888 · Dompé Farmaceutici S.p.A
Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
What this study is about
This is a phase 3, randomly assigned, conducted at multiple hospitals, vehicle-controlled, double-masked study to evaluate the effectiveness and safety of intranasal cenegermin compared with vehicle control in adult participants with NAION.
View original scientific description
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Los Angeles, California
- Newport Beach, California
- Aurora, Colorado
- Miami, Florida
- Sarasota, Florida
- Chicago, Illinois
- Lexington, Kentucky
- Baltimore, Maryland
- Boston, Massachusetts
- Ann Arbor, Michigan
- Grand Rapids, Michigan
- Minneapolis, Minnesota
And 4 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 22, 2026 · Source of record for eligibility and locations