(22578) An open-label, non-randomized, multi-center, phase 4 pharmacokinetic study to evaluate the systemic exposure after bilateral intravitreal administration of high dose (8 mg) aflibercept in adults with diabetic macular edema or neovascular age-related macular degeneration
This research is a study about an existing eye medicine called Eylea, which is used to treat serious eye conditions like wet age-related macular degeneration (nAMD) and diabetic macular oedema (DME). These conditions can cause blurry vision and even vision loss. The study is specifically looking at how much of a higher dose of Eylea gets absorbed into the body when it's given as an injection into both eyes. Researchers want to understand if this higher dose is processed differently by the body compared to the usual dose. This information helps doctors understand the medicine better, but it's important to know this is not a study to test if the medicine works — that's already known for the usual dose. All adults over 18 can potentially join.
At a glance
What is this study about?
This study is about a medicine called Eylea (with the active ingredient aflibercept) that is already approved and used to treat certain eye conditions. Specifically, it's for people who have either 'wet' age-related macular degeneration (nAMD) or diabetic macular oedema (DME). Both of these conditions affect the macula, the central part of your retina that helps you see clearly for reading and recognising faces. They can cause your vision to become blurry or distorted, and if not treated, can lead to permanent vision loss.
The main goal of this particular study is not to see if Eylea works – we already know it’s an effective treatment. Instead, researchers want to understand exactly how a higher dose of Eylea behaves in the body when it's injected into both eyes. They are especially interested in finding out the highest level of the medicine that reaches the bloodstream after these injections. This type of study, called a 'Phase 4 pharmacokinetic study', helps doctors get a more complete picture of how the drug is processed by the body, even after it's been in use for a while.
Understanding how much medicine gets into your system, and how quickly, is important. It helps doctors make sure the treatment is as safe and effective as possible. This study is ‘open-label,’ meaning both you and your study doctor will know you’re receiving the study medicine. It’s also ‘non-randomised,’ which means you won't be randomly assigned to different treatment groups; all participants will receive the same high dose of Eylea in both eyes.
Key takeaways
- This study is about an existing eye medicine called Eylea (aflibercept).
- It's for people with 'wet' age-related macular degeneration or diabetic macular oedema.
- The main aim is to see how a higher dose of Eylea is absorbed by the body, not to test if it works.
- You would receive injections of Eylea into both eyes under close medical supervision.
- The study is for adults aged 18 and over.
Who may be eligible?
To be part of this study, you need to be an adult, 18 years old or older, and have one of two specific eye conditions: either 'wet' age-related macular degeneration (nAMD) or diabetic macular oedema (DME). The study includes both men and women.
There might be other health requirements or, on the other hand, certain medical conditions that would prevent you from taking part. For example, if you have other serious health problems that could affect the study results or your safety, you might not be able to join. All these details will be carefully checked by the study team.
It’s important to talk to your doctor or the study team who can confirm if this study is right for you, based on your full health history and specific eye condition.
- Are you 18 years old or older?
- Do you have 'wet' age-related macular degeneration (nAMD)?
- Or do you have diabetic macular oedema (DME)?
- Are you comfortable with receiving injections in both eyes?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would receive the study medicine, Eylea, which will be injected directly into both of your eyes by a doctor. This is the standard way Eylea is given, although in this study, it's a higher dose than normally used. You would need to attend several appointments at a study clinic or hospital.
During your visits, the study team would perform various assessments to monitor your health and how your body is reacting to the medicine. These might include eye exams, blood tests to measure the level of Eylea in your system, and checks of your general health. The exact number of visits, how long each lasts, and the total duration you would be involved in the study would be explained in detail by the study team. You would likely have follow-up visits to ensure your safety and monitor any effects of the treatment.
Potential risks and benefits
Locations (3)
- —Czechia
- —Slovakia
- —Hungary
Common questions
What is 'wet' age-related macular degeneration (nAMD)?
It's an eye condition where new, abnormal blood vessels grow under the macula (the central part of your retina), leaking fluid and blood, which blurs your vision.
What is diabetic macular oedema (DME)?
DME is an eye complication of diabetes where fluid leaks into the macula, causing it to swell and leading to blurry vision.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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