A Phase 3 interventional study of Cenegermin and Vehicle in Non-Arteritic Anterior Ischemic Optic Neuropathy, sponsored by Dompé Farmaceutici S.p.A. Recruiting at 38 sites in 4 countries. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Dompé Farmaceutici S.p.A · Phase 3, Interventional, and Treatment
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).
55 studies on the registry are indexed under Optic Neuropathy, Ischemic; 11 are open to participants now.
This study's planned enrollment of 272 is above the median of 40 across 35 interventional studies indexed under Optic Neuropathy, Ischemic.
Browse Optic Neuropathy, Ischemic studies →Dompé Farmaceutici S.p.A is the lead sponsor of 52 studies on the registry; 4 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 18 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Additional inclusion/exclusion criteria apply, as defined in the protocol.
Participants will be administered with cenegermin spray in each nostril.
Drug: Cenegermin
Participants will be administered with vehicle spray in each nostril.
Other: Vehicle
Cenegermin is administered intranasally.
Vehicle spray is administered intranasally.
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
Improvement in visual acuity defined as a \>=15 letter increase in BCVA using ETDRS chart.
Time frame: Baseline to Week 24
Change from baseline in visual field mean sensitivity in decibels
Change from baseline in visual field mean sensitivity in decibels will be analyzed
Time frame: Baseline through Week 24
Change from baseline in BCVA as measured by the ETDRS chart
Time frame: 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
Change from baseline in mean sensitivity at week 24 in loci prespecified at baseline will be analyzed.
Time frame: Baseline through Week 24
Change from baseline in ganglion cell layer-inner plexiform layer (GCL-IPL) thickness (micrometer [μm]) on optical coherence tomography (OCT).
Change from baseline in GCL-IPL thickness on optical coherence tomography will be analyzed.
Time frame: Baseline through Week 24
Incidence of ocular and non-ocular adverse events
Number of participants with ocular and non-ocular adverse events will be assessed.
Time frame: Through Week 24
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Cenegermin