Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
Recruiting
Phase 3
Interventional Study
Non-Arteritic Anterior Ischemic Optic Neuropathy
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 50 – 80
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 272 (estimated)
- Sponsor
- Dompé Farmaceutici S.p.A · Industry
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About This Trial
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).
Trial Locations
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Eligibility 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 ocu…
Contacts
Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)
+39 02 583 831
CONTACT