Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
Non-Arteritic Anterior Ischemic Optic Neuropathy
What This Study Is About
- Investigates whether intranasal cenegermin improves vision loss in adults with NAION
- You will receive nasal spray or placebo for several months while being monitored
- May lead to a new safe treatment that could restore some sight
Technical Description
Who Can Participate
- 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.
- A BCVA score in the study eye of ≥ 15 letters and ≤ 65 letters measured using the ETDRS chart.
- Sufficiently clear ocular media and adequate pupil dilation to enable assessment of the optic nerve and retina in both eyes.
- Bilateral NAION or sequential NAION with fellow eye involvement within 6 weeks of study eye involvement.
- Clinical evidence of temporal arteritis (giant cell arteritis) signs or symptoms.
- Pain with eye movement
- Intraocular pressure (IOP) greater than 25 mmHg in the study eye or history of glaucoma in the study eye.
- Intermediate age-related macular degeneration (AMD) with subfoveal drusen, exudative AMD, or geographic atrophy in the study eye.
- Abnormal laboratory findings suggestive of temporal arteritis (giant cell arteritis), in the absence of a known acute cause
View Full 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 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/exclusion criteria apply, as defined in the protocol.
Important: This is a summary. The final determination of eligibility will be made by the trial coordinator after reviewing your complete medical history.
Study Locations
Show all 25 locations
Contact
Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)
Experimental Treatment
This trial is testing a new treatment. Results are not guaranteed. Talk to your doctor before applying.
Your information will be sent to the study coordinator for review.