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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
272
Cenegermin is administered intranasally.
Vehicle spray is administered intranasally.
Neuro Eye Orbit Institute
Los Angeles, California, United States
RECRUITINGDavid Geffen School of Medicine at UCLA - Ophthalmology
Los Angeles, California, United States
NOT_YET_RECRUITINGCalifornia Orbital Consultants
Newport Beach, California, United States
RECRUITINGUniversity of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
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.
Time frame: Baseline to Week 24
Change from baseline in visual field mean sensitivity in decibels
Change from baseline in visual field mean sensitivity in decibels will be analyzed
Time frame: Baseline through Week 24
Change from baseline in BCVA as measured by the ETDRS chart
Time frame: Baseline through Week 24
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.
Time frame: Baseline through Week 24
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.
Time frame: Baseline through Week 24
Incidence of ocular and non-ocular adverse events
Number of participants with ocular and non-ocular adverse events will be assessed.
Time frame: Through Week 24
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Bascom Palmer Eye Institute, University of Miami School of Medicine
Miami, Florida, United States
NOT_YET_RECRUITINGSarasota Retina Institute - Research
Sarasota, Florida, United States
RECRUITINGEmory University - Emory Eye Center - Atlanta
Atlanta, Georgia, United States
RECRUITINGNorthwestern University - Ophthalmology
Chicago, Illinois, United States
NOT_YET_RECRUITINGUniversity of Illinois at Chicago Eye and Ear Infirmary - Ophthalmology
Chicago, Illinois, United States
NOT_YET_RECRUITINGUniv. Of Kentucky Clinic Dept of Ophthalmology & Vision Science
Lexington, Kentucky, United States
NOT_YET_RECRUITING...and 15 more locations