Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
Purpose
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).
Condition
- Non-Arteritic Anterior Ischemic Optic Neuropathy
Eligibility
- Eligible Ages
- Between 50 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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.
Exclusion Criteria
- Bilateral NAION or sequential NAION with fellow eye involvement within 6 weeks of study eye involvement. 2. Clinical evidence of temporal arteritis (giant cell arteritis) signs or symptoms. 3. Abnormal laboratory findings suggestive of temporal arteritis (giant cell arteritis), in the absence of a known acute cause 4. Pain with eye movement 5. Intraocular pressure (IOP) greater than 25 mmHg in the study eye or history of glaucoma in the study eye. 6. Intermediate age-related macular degeneration (AMD) with subfoveal drusen, exudative AMD, or geographic atrophy in the study eye. Note: Additional inclusion/exclusion criteria apply, as defined in the protocol.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
- Masking Description
- The sponsor is also masked to the study treatment.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cenegermin |
Participants will be administered with cenegermin spray in each nostril. |
|
|
Placebo Comparator Vehicle |
Participants will be administered with vehicle spray in each nostril. |
|
Recruiting Locations
Neuro Eye Orbit Institute
Los Angeles, California 90048
Los Angeles, California 90048
California Orbital Consultants
Newport Beach, California 92660
Newport Beach, California 92660
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
Aurora, Colorado 80045
Sarasota Retina Institute - Research
Sarasota, Florida 34239
Sarasota, Florida 34239
Emory University - Emory Eye Center - Atlanta
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Tufts Medical Center - Neurology
Boston, Massachusetts 02116
Boston, Massachusetts 02116
University of Michigan Health - Kellogg Eye Center
Ann Arbor, Michigan 48105
Ann Arbor, Michigan 48105
Trinity Health Grand Rapids
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Mayo Clinic - Department of Ophthalmology
Rochester, Minnesota 55905
Rochester, Minnesota 55905
Washington University School of Medicine in St Louis - Ophthalmology
St Louis, Missouri 63108
St Louis, Missouri 63108
Duke Eye Center - Ophthalmology
Durham, North Carolina 27705
Durham, North Carolina 27705
University of Pennsylvania - Ophthalmology
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Retina Consultants of South Carolina, Charleston Neuroscience Institute- West Ashley (RCA)
Charleston, South Carolina 29414
Charleston, South Carolina 29414
More Details
- Status
- Recruiting
- Sponsor
- Dompé Farmaceutici S.p.A
Study Contact
Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)+39 02 583 831