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).
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.
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
Parallel
Cenegermin
DrugCenegermin is administered intranasally.
Vehicle
Other interventionVehicle spray is administered intranasally.
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.
Change from baseline in visual field mean sensitivity in decibels
Change from baseline in visual field mean sensitivity in decibels will be analyzed
Change from baseline in BCVA as measured by the ETDRS chart
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.
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.
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