Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Is… (NCT07453888) | Clinical Trial Compass
RecruitingPhase 3
Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
United States272 participantsStarted 2026-06-30
Plain-language 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).
Who can participate
Age range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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
Timeframe: Baseline to Week 24
Trial details
NCT IDNCT07453888
SponsorDompé Farmaceutici S.p.A
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-09
Contact for this trial
Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)