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)
Dompé Farmaceutici S.p.A
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
- Age range
- 50–80 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: 1. 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. 2. A BCVA score in the study eye of ≥ 15 letters and ≤ 65 letters measured using the ETDRS chart. 3. Sufficiently clear ocular media and adequate pupil dilation to enable assessment of the optic nerve and retina in both eyes. Key Exclusion Criteria: 1. Bilateral NAION or sequential NAION with fellow eye involvement within 6 weeks of study eye involvement. 2. Clinical evidence of temporal arteritis (giant cell arteriti…
Interventions
- DrugCenegermin
Cenegermin is administered intranasally.
- OtherVehicle
Vehicle spray is administered intranasally.
Locations (38)
- Neuro Eye Orbit InstituteLos Angeles, California
- David Geffen School of Medicine at UCLA - OphthalmologyLos Angeles, California
- California Orbital ConsultantsNewport Beach, California
- Stanford Byers Eye InstitutePalo Alto, California
- UC Davis Health, OphthalmologySacramento, California
- University of Colorado Anschutz Medical CampusAurora, Colorado