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Nasal spray could reverse sudden blindness in groundbreaking trial

NCT ID NCT07453888

Disease control Sponsor: Dompé Farmaceutici S.p.A Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 4 times

Summary

This study tests a nasal spray called cenegermin to see if it can improve vision in people who recently lost eyesight from a condition called NAION (a stroke in the optic nerve). About 272 adults will receive either the spray or a placebo. The goal is to measure if more people gain at least 15 letters on an eye chart after treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 272 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. 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. 2. A BCVA score in the study eye of ≥ 15 letters and ≤ 65 letters measured using the ETDRS chart. 3. Sufficiently clear ocular media and adequate pupil dilation to enable assessment of the optic nerve and retina in both eyes. Key Exclusion Criteria: 1. Bilateral NAION or sequential NAION with fellow eye involvement within 6 weeks of study eye involvement. 2. Clinical evidence of temporal arteritis (giant cell arteritis) signs or symptoms. 3. Abnormal laboratory findings suggestive of temporal arteritis (giant cell arteritis), in the absence of a known acute cause 4. Pain with eye movement 5. Intraocular pressure (IOP) greater than 25 mmHg in the study eye or history of glaucoma in the study eye. 6. 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.

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Conditions

The condition(s) this trial relates to.

anterior ischemic optic neuropathy non-arteritic anterior ischemic optic neuropathy optic nerve disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-arteritic anterior ischemic optic neuropathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    25 sites in 3 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bascom Palmer Eye Institute, University of Miami School of Medicine

    NOT_YET_RECRUITING

    Miami, Florida, 33136, United States

  • California Orbital Consultants

    RECRUITING

    Newport Beach, California, 92660, United States

  • David Geffen School of Medicine at UCLA - Ophthalmology

    NOT_YET_RECRUITING

    Los Angeles, California, 90095, United States

  • Duke Eye Center - Ophthalmology

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Emory University - Emory Eye Center - Atlanta

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital - St Paul's Eye Unit

    RECRUITING

    Liverpool, L7 8TX, United Kingdom

  • Mayo Clinic - Department of Ophthalmology

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Neuro Eye Clinical Trials

    RECRUITING

    Houston, Texas, 77074, United States

  • Neuro Eye Orbit Institute

    RECRUITING

    Los Angeles, California, 90048, United States

  • Northwestern University - Ophthalmology

    NOT_YET_RECRUITING

    Chicago, Illinois, 60611, United States

  • Retina Consultants of South Carolina, Charleston Neuroscience Institute- West Ashley (RCA)

    RECRUITING

    Charleston, South Carolina, 29414, United States

  • Sarasota Retina Institute - Research

    RECRUITING

    Sarasota, Florida, 34239, United States

    Contact Email: •••••@•••••

  • The Johns Hopkins Hospital (JHH)

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21287, United States

  • Trinity Health Grand Rapids

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Tufts Medical Center - Neurology

    RECRUITING

    Boston, Massachusetts, 02116, United States

  • Univ. Of Kentucky Clinic Dept of Ophthalmology & Vision Science

    NOT_YET_RECRUITING

    Lexington, Kentucky, 40508, United States

  • University of Colorado Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Illinois at Chicago Eye and Ear Infirmary - Ophthalmology

    NOT_YET_RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Michigan Health - Kellogg Eye Center

    RECRUITING

    Ann Arbor, Michigan, 48105, United States

  • University of Minnesota, Dept of Ophthalmology

    NOT_YET_RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Pennsylvania - Ophthalmology

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Vision SA - Ophthalmology

    RECRUITING

    Kent Town, South Australia, 5067, Australia

  • Washington University School of Medicine in St Louis - Ophthalmology

    RECRUITING

    St Louis, Missouri, 63108, United States

  • Western Eye Hospital

    RECRUITING

    London, Greater London, NW1 5QH, United Kingdom

  • Wills Eye Hospital

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19107, United States