Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
Condition(s) studied
Investigational drug(s) / intervention(s)
Cenegermin: Cenegermin is administered intranasally.
Vehicle: Vehicle spray is administered intranasally.
Study 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).
Eligibility
Primary outcome measure(s)
- 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 — Baseline to Week 24
Improvement in visual acuity defined as a \>=15 letter increase in BCVA using ETDRS chart.
Trial sites (38)
| Facility | City | Region | Status |
|---|---|---|---|
| Neuro Eye Orbit Institute | Los Angeles | California | Recruiting |
| David Geffen School of Medicine at UCLA - Ophthalmology | Los Angeles | California | Not Yet Recruiting |
| California Orbital Consultants | Newport Beach | California | Recruiting |
| Stanford Byers Eye Institute | Palo Alto | California | Recruiting |
| UC Davis Health, Ophthalmology | Sacramento | California | Recruiting |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | Recruiting |
| Bascom Palmer Eye Institute, University of Miami School of Medicine | Miami | Florida | Not Yet Recruiting |
| Sarasota Retina Institute - Research | Sarasota | Florida | Recruiting |
| University of South Florida/Ophthalmology | Tampa | Florida | Recruiting |
| Emory University - Emory Eye Center - Atlanta | Atlanta | Georgia | Recruiting |
| Northwestern University - Ophthalmology | Chicago | Illinois | Recruiting |
| University of Illinois at Chicago Eye and Ear Infirmary - Ophthalmology | Chicago | Illinois | Recruiting |
| Univ. Of Kentucky Clinic Dept of Ophthalmology & Vision Science | Lexington | Kentucky | Not Yet Recruiting |
| The Johns Hopkins Hospital (JHH) | Baltimore | Maryland | Recruiting |
| Tufts Medical Center - Neurology | Boston | Massachusetts | Recruiting |
| University of Michigan Health - Kellogg Eye Center | Ann Arbor | Michigan | Recruiting |
| Trinity Health Grand Rapids | Grand Rapids | Michigan | Recruiting |
| University of Minnesota, Dept of Ophthalmology | Minneapolis | Minnesota | Recruiting |
| Mayo Clinic - Department of Ophthalmology | Rochester | Minnesota | Recruiting |
| Washington University School of Medicine in St Louis - Ophthalmology | St Louis | Missouri | Recruiting |
| UNMC Truhlsen Eye Institute | Omaha | Nebraska | Recruiting |
| Duke Eye Center - Ophthalmology | Durham | North Carolina | Recruiting |
| University of Pennsylvania - Ophthalmology | Philadelphia | Pennsylvania | Recruiting |
| Wills Eye Hospital | Philadelphia | Pennsylvania | Not Yet Recruiting |
| Retina Consultants of South Carolina, Charleston Neuroscience Institute- West Ashley (RCA) | Charleston | South Carolina | Recruiting |
| Neuro Eye Clinical Trials | Houston | Texas | Recruiting |
| Retina Consultants of Texas - The Woodlands | The Woodlands | Texas | Recruiting |
| Vision SA - Ophthalmology | Kent Town | South Australia | Recruiting |
| Cerulea | East Melbourne | Victoria | Recruiting |
| Pusan National University Hospital - Ophthalmology | Busan | Busan Gwang'yeogsi | Recruiting |
| Asan Medical Center - Ophthalmology | Seoul | Seoul Teugbyeolsi | Recruiting |
| Samsung Medical Center - Ophthalmology | Seoul | Seoul Teugbyeolsi | Recruiting |
| Western Eye Hospital | London | Greater London | Recruiting |
| Manchester University NHS Foundation Trust - Manchester Royal Eye Hospital | Manchester | Greater Manchester | Recruiting |
| Oxford University Hospital NHS Trust - John Radcliffe Hospital | Abingdon | Oxfordshire | Recruiting |
| Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital | York | Sheffield | Recruiting |
| Bristol NHS Foundation Trust - Bristol Eye Hospital | Bristol | United Kingdom | Recruiting |
| Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital - St Paul's Eye Unit | Liverpool | United Kingdom | Recruiting |
More Dompé Farmaceutici S.p.A trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07453888 on ClinicalTrials.gov ↗ ← All trials in the UK