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Non-Arteritic Anterior Ischemic Optic NeuropathyPhase 3NCT07453888

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

A Phase 3 study testing Cenegermin in people with Non-Arteritic Anterior Ischemic Optic Neuropathy, run by Dompé Farmaceutici S.p.A at 38 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 to 80 years
What is being tested?
Cenegermin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
272 participants
Where
38 sitesin 4 countries
Study dates
1 Jul 2026to Sep 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

38 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

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

+39 02 583 831

38 sites in 4 countries

United States27 sites, 27 recruiting

  • University of Michigan Health - Kellogg Eye Center

    Ann Arbor, Michigan, 48105

    734-763-0482, ldelott@med.umich.edu

    Lindsey DeLott

    Recruiting

  • Emory University - Emory Eye Center - Atlanta

    Atlanta, Georgia, 30322

    404-778-2020, michael.dattilo@emory.edu

    Michael Dattilo

    Recruiting

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

    303-724-9008, prem.subramanian@ucdenver.edu

    Prem Subramanian

    Recruiting

  • The Johns Hopkins Hospital (JHH)

    Baltimore, Maryland, 21287

    667-306-7723, ahende24@jhmi.edu

    Amanda Henderson

    Recruiting

  • Tufts Medical Center - Neurology

    Boston, Massachusetts, 02116

    617-636-5489, Laurel.Vuong@tuftsmedicine.org

    Laurel Vuong

    Recruiting

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

    Charleston, South Carolina, 29414

    843-763-4466, john.kerrison@retinasouthcarolina.com

    John Kerrison

    Recruiting

  • Northwestern University - Ophthalmology

    Chicago, Illinois, 60611

    312-926-0747, shira.simon@northwestern.edu

    Shira Simon

    Recruiting

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

    Chicago, Illinois, 60612

    312-413-7491, Pmacint1@uic.edu

    Peter MacIntosh

    Recruiting

  • Duke Eye Center - Ophthalmology

    Durham, North Carolina, 27705

    919-668-0558, sid.gospe@duke.edu

    Sidney Gospe

    Recruiting

  • Trinity Health Grand Rapids

    Grand Rapids, Michigan, 49503

    616-685-6306, santosro@trinity-health.org

    Ronel Santos

    Recruiting

  • Neuro Eye Clinical Trials

    Houston, Texas, 77074

    346-429-4135, rosatang.md@me.com

    Rosa Tang

    Recruiting

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

    Lexington, Kentucky, 40508

    859-323-0028, padmaja.sudhakar@uky.edu

    Padmaja Sudhakar

    Not yet recruiting

  • Neuro Eye Orbit Institute

    Los Angeles, California, 90048

    310-469-9080, sbose@neuroeyeorbit.com

    Swaraj Bose

    Recruiting

  • David Geffen School of Medicine at UCLA - Ophthalmology

    Los Angeles, California, 90095

    626-817-4701, quiros@jsei.ucla.edu

    Peter Quiros

    Not yet recruiting

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

    Miami, Florida, 33136

    305-243-1250, blam@med.miami.edu

    Byron Lam

    Not yet recruiting

  • University of Minnesota, Dept of Ophthalmology

    Minneapolis, Minnesota, 55455

    612-273-6212, mikelee@umn.edu

    Michael Lee

    Recruiting

  • California Orbital Consultants

    Newport Beach, California, 92660

    626-475-0989, Madhu.agarwal@nvisioncenters.com

    Madhu Agarwal

    Recruiting

  • UNMC Truhlsen Eye Institute

    Omaha, Nebraska, 68105

    402-559-1852, slynch@unmc.edu

    Shannon Lynch

    Recruiting

  • Stanford Byers Eye Institute

    Palo Alto, California, 94303

    650-723-6995, yjliao@stanford.edu

    Yaping Joyce Liao

    Recruiting

  • University of Pennsylvania - Ophthalmology

    Philadelphia, Pennsylvania, 19104

    215-662-8696, madhura.tamhankar@pennmedicine.upenn.edu

    Madhura Tamhankar

    Recruiting

  • Wills Eye Hospital

    Philadelphia, Pennsylvania, 19107

    215-825-4787, Danijel.j.pericic@gmail.com

    Danijel Pericic

    Not yet recruiting

  • Mayo Clinic - Department of Ophthalmology

    Rochester, Minnesota, 55905

    480-574-1160, chen.john@mayo.edu

    John Chen

    Recruiting

  • UC Davis Health, Ophthalmology

    Sacramento, California, 95817

    800-482-3284, aycliu@health.ucdavis.edu

    Yin Allison Liu

    Recruiting

  • Sarasota Retina Institute - Research

    Sarasota, Florida, 34239

    941-921-5335, sri30research@aol.com

    Marc Levy

    Recruiting

  • Washington University School of Medicine in St Louis - Ophthalmology

    St Louis, Missouri, 63108

    314-286-2946, vanstaverng@wustl.edu

    Gregory Van Stavern

    Recruiting

  • University of South Florida/Ophthalmology

    Tampa, Florida, 33612

    813-974-2020, asriram2@usf.edu

    Aishwarya Sriram

    Recruiting

  • Retina Consultants of Texas - The Woodlands

    The Woodlands, Texas, 77384

    713-524-3434, svsmd@retinaconsultantstexas.com

    Stacy Smith

    Recruiting

Other trials in United States

United Kingdom6 sites, 6 recruiting

  • Oxford University Hospital NHS Trust - John Radcliffe Hospital

    Abingdon, Oxfordshire, OX3 9DU

    4400000000, srilakshmi.sharma@ouh.nhs.uk

    Srilakshmi Sharma

    Recruiting

  • Bristol NHS Foundation Trust - Bristol Eye Hospital

    Bristol, BS1 2LX

    01173424770, simon.epps@uhbw.nhs.uk

    Simon Epps

    Recruiting

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

    Liverpool, L7 8TX

    0151 706 3874, nima.ghadiri@liverpoolft.nhs.uk

    Nima Ghadiri

    Recruiting

  • Western Eye Hospital

    London, Greater London, NW1 5QH

    4401753636210, richard.nicholas3@nhs.net

    Richard Nicholas

    Recruiting

  • Manchester University NHS Foundation Trust - Manchester Royal Eye Hospital

    Manchester, Greater Manchester, M13 9WL

    01617010826, ali.yagan@mft.nhs.uk

    Ali Yagan

    Recruiting

  • Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital

    York, Sheffield, S10 2JF

    4401142712619, simon.hickman@nhs.net

    Simon Hickman

    Recruiting

Other trials in United Kingdom

South Korea3 sites, 3 recruiting

  • Pusan National University Hospital - Ophthalmology

    Busan, Busan Gwang'yeogsi, 49241

    82-51-240-7000, hychoi@pusan.ac.kr

    Hee-young Choi

    Recruiting

  • Asan Medical Center - Ophthalmology

    Seoul, Seoul Teugbyeolsi, 05505

    82-2-3010-5001, bjlee99@amc.seoul.kr

    Byung Joo Lee

    Recruiting

  • Samsung Medical Center - Ophthalmology

    Seoul, Seoul Teugbyeolsi, 06351

    82-2-3410-0200, kyungahh.park@samsung.com

    Kyung Ah Park

    Recruiting

Other trials in South Korea

Australia2 sites, 2 recruiting

  • Cerulea

    East Melbourne, Victoria, 3002

    0399590051, shivanand.sheth@eyeandear.org.au

    Shivanand Sheth

    Recruiting

  • Vision SA - Ophthalmology

    Kent Town, South Australia, 5067

    61882044899, celia.chen@health.sa.gov.au

    Celia Chen

    Recruiting

Other trials in Australia

About this study

Official 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)

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).

Being tested
Cenegermin, Vehicle
Keywords
Acute optic neuropathy, Non-Arteritic Anterior Ischemic Optic Neuropathy, NAION, cenegermin, Optic neuropathy, Intranasal
Medical subject headings
Optic Neuropathy, Ischemic, Optic Nerve Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CenegerminDrug

    Cenegermin is administered intranasally.

  • VehicleOther

    Vehicle spray is administered intranasally.

Study groups in NCT07453888
Study groupRoleWhat they receive
CenegerminExperimentalParticipants will be administered with cenegermin spray in each nostril.
Receives: Drug: Cenegermin
VehiclePlacebo comparatorParticipants will be administered with vehicle spray in each nostril.
Receives: Other: Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to Week 24

Secondary outcomes (5)

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

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

    Measured: Baseline through Week 24

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

    Measured: 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

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

    Measured: Baseline through Week 24

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

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

    Measured: Baseline through Week 24

  5. Incidence of ocular and non-ocular adverse events

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

    Measured: Through Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2026
  2. Study start1 Jul 2026
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
272 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07453888
Sponsor's protocol ID
NGF-NAION-301
Status last verified
Oct 2026
First submitted
2 Mar 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cenegermin in people with Non-Arteritic Anterior Ischemic Optic Neuropathy, run by Dompé Farmaceutici S.p.A at 38 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, United Kingdom, South Korea, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI) (+39 02 583 831), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07453888.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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