Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
Conditions
Brief summary
Improvement in Best Corrected Visual Acuity (BCVA), defined as a ≥ 15 letter gain from baseline to Week 24, measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
Detailed description
Change from baseline through Week 24 in visual field mean sensitivity, in a prespecified region consisting of at least 5 separate loci on visual field testing, Change from baseline through Week 24 in BCVA as measured by the ETDRS chart., Change from baseline through Week 24 in visual field mean sensitivity in decibels., Change from baseline through Week 24 in ganglion cell layer-inner plexiform layer (GCL-IPL) thickness (μm) on optical coherence tomography (OCT).
Interventions
DRUGCenegermin
DRUGVehicle for cenegermin drug product
Sponsors
Dompe' Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in Best Corrected Visual Acuity (BCVA), defined as a ≥ 15 letter gain from baseline to Week 24, measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline through Week 24 in visual field mean sensitivity, in a prespecified region consisting of at least 5 separate loci on visual field testing, Change from baseline through Week 24 in BCVA as measured by the ETDRS chart., Change from baseline through Week 24 in visual field mean sensitivity in decibels., Change from baseline through Week 24 in ganglion cell layer-inner plexiform layer (GCL-IPL) thickness (μm) on optical coherence tomography (OCT). | — |
Outcome results
None listed