Non-Arteritic Anterior Ischemic Optic Neuropathy
Conditions
Keywords
Acute optic neuropathy, Non-Arteritic Anterior Ischemic Optic Neuropathy, NAION, cenegermin, Optic neuropathy, Intranasal
Brief 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).
Interventions
DRUGCenegermin
Cenegermin is administered intranasally.
OTHERVehicle
Vehicle spray is administered intranasally.
Sponsors
Dompé Farmaceutici S.p.A
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The sponsor is also masked to the study treatment.
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline to Week 24 | Improvement in visual acuity defined as a \>=15 letter increase in BCVA using ETDRS chart. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in visual field mean sensitivity in decibels | Baseline through Week 24 | Change from baseline in visual field mean sensitivity in decibels will be analyzed |
| Change from baseline in BCVA as measured by the ETDRS chart | 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 | Baseline through Week 24 | 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). | Baseline through Week 24 | Change from baseline in GCL-IPL thickness on optical coherence tomography will be analyzed. |
| Incidence of ocular and non-ocular adverse events | Through Week 24 | Number of participants with ocular and non-ocular adverse events will be assessed. |
Countries
Australia, United Kingdom, United States
Contacts
CONTACTDompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)
Outcome results
None listed