Evaluate the efficacy of intranasal cenegermin compared to vehicle on improving the visual acuity in participants with Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION).
NAION
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)
(NAION)
Optic nerve disorders
All genders
50-80
Recruiting now
Overview
Principal Investigator: Laurel Vuong, MD
Contact Us
Lainey Mullen
Study details
Inclusion Criteria
- Confirmed clinical diagnosis of unilateral NAION in the study eye with symptom onset within the past 14 days
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form
Exclusion Criteria
- Pain with eye movement
- Uncontrolled diabetes mellitus (HbA1c greater than or equal to 8.0%)
- Malignancy
Study Requirements
The length of participation for this study is 26 weeks including the screening period and there will be 9 visits. There will be blood draws at 7 of the 9 visits. There will be questionnaires, photos, and other vision assesments.