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Tests treatment safety and results for Non-Arteritic Anterior Ischemic Optic Neuropathy
Official title Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
ClinicalTrials.gov ID: NCT07453888
What this study is testing
What is Cenegermin?
Cenegermin is an investigational medicine, being studied as a potential treatment for non-arteritic anterior ischemic optic neuropathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 80
You may be able to join if
- 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. Key
You likely can't join if
- 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.
- Abnormal laboratory findings suggestive of temporal arteritis (giant cell arteritis), in the absence of a known acute cause
- 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. Note: Additional...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Newport Beach, California, United States
- Aurora, Colorado, United States
- Miami, Florida, United States
- Sarasota, Florida, United States
- Chicago, Illinois, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Grand Rapids, Michigan, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- Philadelphia, Pennsylvania, United States
- Charleston, South Carolina, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Newport Beach, California, United States; Aurora, Colorado, United States; Miami, Florida, United States; Sarasota, Florida, United States; Chicago, Illinois, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.