What this study is
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).
What's being tested
- Cenegermin
Intervention · DRUG
Cenegermin is administered intranasally.
- Vehicle
Intervention · OTHER
Vehicle spray is administered intranasally.
Study details
- 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)
- Sponsor
- Dompé Farmaceutici S.p.A
- Conditions
- Non-Arteritic Anterior Ischemic Optic Neuropathy
- Enrolling
- 272 people
- Starts
- 2026-07-01
- Est. completion
- 2027-09
- Design
- Triple-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 50 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (38)
38 openNeuro Eye Orbit Institute
Los Angeles, California, United States
- Contact310-469-9080sbose@neuroeyeorbit.com
- Swaraj Bose · Principal investigator
RecruitingDavid Geffen School of Medicine at UCLA - Ophthalmology
Los Angeles, California, United States
- Contact626-817-4701quiros@jsei.ucla.edu
- Peter Quiros · Principal investigator
Not yet recruitingCalifornia Orbital Consultants
Newport Beach, California, United States
- Contact626-475-0989Madhu.agarwal@nvisioncenters.com
- Madhu Agarwal · Principal investigator
RecruitingStanford Byers Eye Institute
Palo Alto, California, United States
- Contact650-723-6995yjliao@stanford.edu
- Yaping Joyce Liao · Principal investigator
RecruitingUC Davis Health, Ophthalmology
Sacramento, California, United States
- Contact800-482-3284aycliu@health.ucdavis.edu
- Yin Allison Liu · Principal investigator
RecruitingUniversity of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
- Contact303-724-9008prem.subramanian@ucdenver.edu
- Prem Subramanian · Principal investigator
RecruitingBascom Palmer Eye Institute, University of Miami School of Medicine
Miami, Florida, United States
- Contact305-243-1250blam@med.miami.edu
- Byron Lam · Principal investigator
Not yet recruitingSarasota Retina Institute - Research
Sarasota, Florida, United States
- Contact941-921-5335sri30research@aol.com
- Marc Levy · Principal investigator
RecruitingUniversity of South Florida/Ophthalmology
Tampa, Florida, United States
- Contact813-974-2020asriram2@usf.edu
- Aishwarya Sriram · Principal investigator
RecruitingEmory University - Emory Eye Center - Atlanta
Atlanta, Georgia, United States
- Contact404-778-2020michael.dattilo@emory.edu
- Michael Dattilo · Principal investigator
RecruitingNorthwestern University - Ophthalmology
Chicago, Illinois, United States
- Contact312-926-0747shira.simon@northwestern.edu
- Shira Simon · Principal investigator
RecruitingUniversity of Illinois at Chicago Eye and Ear Infirmary - Ophthalmology
Chicago, Illinois, United States
- Contact312-413-7491Pmacint1@uic.edu
- Peter MacIntosh · Principal investigator
RecruitingUniv. Of Kentucky Clinic Dept of Ophthalmology & Vision Science
Lexington, Kentucky, United States
- Contact859-323-0028padmaja.sudhakar@uky.edu
- Padmaja Sudhakar · Principal investigator
Not yet recruitingThe Johns Hopkins Hospital (JHH)
Baltimore, Maryland, United States
- Contact667-306-7723ahende24@jhmi.edu
- Amanda Henderson · Principal investigator
RecruitingTufts Medical Center - Neurology
Boston, Massachusetts, United States
- Contact617-636-5489Laurel.Vuong@tuftsmedicine.org
- Laurel Vuong · Principal investigator
RecruitingUniversity of Michigan Health - Kellogg Eye Center
Ann Arbor, Michigan, United States
- Contact734-763-0482ldelott@med.umich.edu
- Lindsey DeLott · Principal investigator
RecruitingTrinity Health Grand Rapids
Grand Rapids, Michigan, United States
- Contact616-685-6306santosro@trinity-health.org
- Ronel Santos · Principal investigator
RecruitingUniversity of Minnesota, Dept of Ophthalmology
Minneapolis, Minnesota, United States
- Contact612-273-6212mikelee@umn.edu
- Michael Lee · Principal investigator
RecruitingMayo Clinic - Department of Ophthalmology
Rochester, Minnesota, United States
- Contact480-574-1160chen.john@mayo.edu
- John Chen · Principal investigator
RecruitingWashington University School of Medicine in St Louis - Ophthalmology
St Louis, Missouri, United States
- Contact314-286-2946vanstaverng@wustl.edu
- Gregory Van Stavern · Principal investigator
RecruitingUNMC Truhlsen Eye Institute
Omaha, Nebraska, United States
- Contact402-559-1852slynch@unmc.edu
- Shannon Lynch · Principal investigator
RecruitingDuke Eye Center - Ophthalmology
Durham, North Carolina, United States
- Contact919-668-0558sid.gospe@duke.edu
- Sidney Gospe · Principal investigator
RecruitingUniversity of Pennsylvania - Ophthalmology
Philadelphia, Pennsylvania, United States
- Contact215-662-8696madhura.tamhankar@pennmedicine.upenn.edu
- Madhura Tamhankar · Principal investigator
RecruitingWills Eye Hospital
Philadelphia, Pennsylvania, United States
- Contact215-825-4787Danijel.j.pericic@gmail.com
- Danijel Pericic · Principal investigator
Not yet recruitingRetina Consultants of South Carolina, Charleston Neuroscience Institute- West Ashley (RCA)
Charleston, South Carolina, United States
- Contact843-763-4466john.kerrison@retinasouthcarolina.com
- John Kerrison · Principal investigator
RecruitingNeuro Eye Clinical Trials
Houston, Texas, United States
- Contact346-429-4135rosatang.md@me.com
- Rosa Tang · Principal investigator
RecruitingRetina Consultants of Texas - The Woodlands
The Woodlands, Texas, United States
- Contact713-524-3434svsmd@retinaconsultantstexas.com
- Stacy Smith · Principal investigator
Recruiting
11 sites outside the US
Vision SA - Ophthalmology
Kent Town, South Australia, Australia
- Contact61882044899celia.chen@health.sa.gov.au
- Celia Chen · Principal investigator
RecruitingCerulea
East Melbourne, Victoria, Australia
- Contact0399590051shivanand.sheth@eyeandear.org.au
- Shivanand Sheth · Principal investigator
RecruitingPusan National University Hospital - Ophthalmology
Busan, Busan Gwang'yeogsi, South Korea
- Contact82-51-240-7000hychoi@pusan.ac.kr
- Hee-young Choi · Principal investigator
RecruitingAsan Medical Center - Ophthalmology
Seoul, Seoul Teugbyeolsi, South Korea
- Contact82-2-3010-5001bjlee99@amc.seoul.kr
- Byung Joo Lee · Principal investigator
RecruitingSamsung Medical Center - Ophthalmology
Seoul, Seoul Teugbyeolsi, South Korea
- Contact82-2-3410-0200kyungahh.park@samsung.com
- Kyung Ah Park · Principal investigator
RecruitingWestern Eye Hospital
London, Greater London, United Kingdom
- Contact4401753636210richard.nicholas3@nhs.net
- Richard Nicholas · Principal investigator
RecruitingManchester University NHS Foundation Trust - Manchester Royal Eye Hospital
Manchester, Greater Manchester, United Kingdom
- Contact01617010826ali.yagan@mft.nhs.uk
- Ali Yagan · Principal investigator
RecruitingOxford University Hospital NHS Trust - John Radcliffe Hospital
Abingdon, Oxfordshire, United Kingdom
- Contact4400000000srilakshmi.sharma@ouh.nhs.uk
- Srilakshmi Sharma · Principal investigator
RecruitingSheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital
York, Sheffield, United Kingdom
- Contact4401142712619simon.hickman@nhs.net
- Simon Hickman · Principal investigator
RecruitingBristol NHS Foundation Trust - Bristol Eye Hospital
Bristol, United Kingdom
- Contact01173424770simon.epps@uhbw.nhs.uk
- Simon Epps · Principal investigator
RecruitingLiverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital - St Paul's Eye Unit
Liverpool, United Kingdom
- Contact0151 706 3874nima.ghadiri@liverpoolft.nhs.uk
- Nima Ghadiri · Principal investigator
Recruiting
Study team
Sponsor
Dompé Farmaceutici S.p.A
Study ID NGF-NAION-301
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.