Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
This research study is for adults aged 50 to 80 who have a sudden vision problem in one eye called Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION). It's a Phase 3 study, which means the treatment has already been tested in earlier stages. We are looking at a nasal spray medicine called Cenegermin. Participants will be split into two groups by chance: one group will receive the Cenegermin nasal spray, and the other will receive a dummy nasal spray (called a 'vehicle'). Neither the patient nor their doctor will know which spray they are getting. The main goal is to find out if Cenegermin can help improve vision and if it is safe to use for people with NAION.
At a glance
What is this study about?
Imagine your eye's main nerve, the optic nerve, is like a cable carrying messages to your brain. If the blood supply to this nerve is suddenly reduced, it can cause problems with your vision. This condition is called Non-Arteritic Anterior Ischemic Optic Neuropathy, or NAION for short. It usually affects one eye at a time and can lead to sudden vision loss.
Currently, there aren't many treatments specifically for NAION. This study aims to test a new medicine called Cenegermin, which is given as a nasal spray. Researchers want to see if this medicine can help repair the damage to the optic nerve and improve vision for people who have recently developed NAION. By taking part, you could help doctors understand if Cenegermin is a safe and effective treatment that could eventually become available to more people.
This is a 'Phase 3' study, meaning it's a large trial that follows earlier successful tests. It's also 'randomised' (meaning people are assigned to treatment groups by chance), 'vehicle-controlled' (meaning some people get a dummy treatment for comparison), and 'double-masked' (meaning neither you nor your study doctor will know which treatment you are receiving). This helps ensure the results are fair and unbiased.
Key takeaways
- This study is testing a nasal spray (Cenegermin) for a sudden vision problem called NAION.
- It's for adults aged 50-80 who recently developed NAION in one eye.
- Participants will either receive the active medicine or a dummy spray.
- Neither you nor your doctor will know which treatment you are getting.
- The study aims to see if Cenegermin can improve vision and is safe.
- Regular eye exams and health checks will be part of your participation.
Who may be eligible?
This study is looking for adults aged between 50 and 80. You might be able to join if you have recently experienced sudden vision changes in one eye due to NAION, and this happened within the last 14 days.
Your vision in the affected eye needs to be within a certain range – not too good, but not severely poor. Also, your eye doctor must be able to get a clear view of the back of your eye to assess the optic nerve and retina. You should not have NAION in both eyes at the same time, or have had it in your other eye very recently.
There are also some reasons why you might not be able to join. For example, if you have another condition called temporal arteritis (a type of inflammation), high pressure inside your eye (glaucoma), or certain other eye problems like advanced age-related macular degeneration. Your doctor will carefully check all these points to see if the study is right for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 50 and 80 years old?
- Have you recently experienced new NAION in one eye (within the last 14 days)?
- Is your vision in the affected eye within a certain range (not too bad, not too good)?
- Do you *not* have certain other eye conditions like glaucoma or advanced macular degeneration?
- Do you *not* have a different condition called temporal arteritis?
- Is your other eye free from NAION, or has it not been affected recently?
What does participation involve?
If you join this study, you'll be assigned by chance to one of two groups. One group will use the Cenegermin nasal spray, and the other will use a dummy nasal spray (which looks and feels the same but contains no active medicine). You will use the nasal spray as directed for a set period.
Throughout the study, you'll have regular visits to the clinic. These visits will involve various checks and tests, such as eye exams to measure your vision and look at the health of your optic nerve. There will also be general health checks. These appointments help the doctors monitor your condition and see if the treatment is working and if you are experiencing any side effects.
Your involvement will include follow-up appointments after you stop using the spray to make sure everything is okay. The total duration of your participation will be explained to you in detail by the study team.
Potential risks and benefits
Locations (25)
- Neuro Eye Orbit InstituteVerified postcodeLos Angeles, United States· Recruiting
- David Geffen School of Medicine at UCLA - OphthalmologyVerified postcodeLos Angeles, United States· Not yet recruiting
- California Orbital ConsultantsVerified postcodeNewport Beach, United States· Recruiting
- University of Colorado Anschutz Medical CampusVerified postcodeAurora, United States· Recruiting
- Bascom Palmer Eye Institute, University of Miami School of MedicineVerified postcodeMiami, United States· Not yet recruiting
- Sarasota Retina Institute - ResearchVerified postcodeSarasota, United States· Recruiting
- Emory University - Emory Eye Center - AtlantaVerified postcodeAtlanta, United States· Recruiting
- Northwestern University - OphthalmologyVerified postcodeChicago, United States· Not yet recruiting
- University of Illinois at Chicago Eye and Ear Infirmary - OphthalmologyVerified postcodeChicago, United States· Not yet recruiting
- Univ. Of Kentucky Clinic Dept of Ophthalmology & Vision ScienceVerified postcodeLexington, United States· Not yet recruiting
- The Johns Hopkins Hospital (JHH)Verified postcodeBaltimore, United States· Not yet recruiting
- Tufts Medical Center - NeurologyVerified postcodeBoston, United States· Recruiting
Common questions
What is NAION?
NAION is a sudden vision problem that happens when the blood supply to the optic nerve (the nerve connecting your eye to your brain) is reduced, causing damage and vision loss, usually in one eye.
What is Cenegermin?
Cenegermin is the name of the experimental medicine being tested in this study. It's given as a nasal spray and aims to help repair the optic nerve.
Why is it 'double-masked'?
Being 'double-masked' means neither you nor your doctor will know if you're getting the active medicine or the dummy spray. This helps ensure the results are fair and unbiased.
Will I have to pay to be in the study?
No, you will not have to pay for the study treatment or for any of the study-related appointments and tests.
Can I stop being in the study whenever I want?
Yes, you are free to leave the study at any time, for any reason, without it affecting your usual medical care.
How to find out more
Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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