(22153) Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of Aflibercept 8 mg in Macular Edema Secondary to Retinal Vein Occlusion
This research study is about a problem called macular edema, which happens when fluid builds up at the back of your eye after a blocked blood vessel, making your vision blurry. Doctors are testing a new version of a medicine called Aflibercept (also known as Eylea) to see if it can improve eyesight and reduce this fluid. They want to find out if this newer version, given in a different way, is as good as or better than the standard Eylea treatment. The study will look at how much people's vision improves and if the treatment is safe, comparing it carefully to what's already available. This is a "Phase 3" study, which means it's one of the final steps before a new medicine might become available to everyone.
At a glance
What is this study about?
This study is looking into a new way to treat a common eye condition called macular edema. This condition happens when a blood vessel in the retina (the light-sensitive tissue at the back of your eye) gets blocked, leading to swelling and fluid build-up. This fluid can make your vision blurry or distorted, sometimes described as a blind spot. The standard treatment often involves injections of a medicine called Eylea directly into the eye.
In this study, researchers are testing a new version of Aflibercept, the active ingredient in Eylea. They want to see if an 8 mg dose of this new version, given possibly less often, is just as safe and effective as the current standard dose. The main goal is to find out if people's eyesight improves and if the fluid in their eye reduces. They will carefully compare the vision changes and safety of the new treatment against the existing one.
This is a very important "Phase 3" study. This means that if the new treatment proves to be safe and effective, it could potentially become a new option for people with macular edema caused by a retinal vein occlusion. Ultimately, the aim is to find better ways to help people keep their vision clear.
Key takeaways
- Tests a new version of Eylea for blurry vision caused by fluid in the eye.
- Compares it to the current standard Eylea treatment.
- Aims to see if the new version is safe, effective, and potentially easier to use.
- Involves regular eye injections and check-ups.
- Participation lasts over a year, with close monitoring.
Who may be eligible?
To be part of this study, you must be at least 18 years old. Both men and women can participate. The study is specifically for people who have been diagnosed with macular edema, which is eye swelling caused by a blocked blood vessel in the back of the eye. This blockage is often referred to as a retinal vein occlusion.
There will be other specific health requirements that your eye doctor will need to check to make sure the study is a good fit for you. These might include details about your overall health and the condition of your eyes. For example, they'll need to confirm that your specific type of eye swelling is due to this particular problem.
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 18 years old or older?
- Have you been diagnosed with blurry vision due to macular edema from a retinal vein occlusion?
- Are you able to attend regular clinic appointments for over a year?
- Are you comfortable with receiving injections into your eye?
- Do you have a general good state of health as determined by your doctor?
What does participation involve?
If you join this study, it will involve regular visits to the clinic for medical check-ups and eye examinations. You will receive injections of the study medicine (either the new Aflibercept 8 mg or the standard Eylea) into your eye at these visits. The doctors will also use special eye scans, like fluorescein angiography, to take pictures of your eye and monitor the fluid.
You will need to complete questionnaires about your vision and how it affects your daily life. The study will follow you closely for about 64 weeks (around 1 year and 3 months) to see how your vision changes and to check for any side effects. The frequency of injections might change over time, depending on how your eye responds to the treatment.
Potential risks and benefits
Locations (14)
- —UnverifiedFrance
- —UnverifiedSlovakia
- —UnverifiedPortugal
- —UnverifiedLithuania
- —UnverifiedHungary
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedCzechia
- —UnverifiedAustria
- —UnverifiedLatvia
- —UnverifiedEstonia
- —UnverifiedBulgaria
Common questions
What is macular edema?
It's swelling at the back of your eye (the macula) caused by a blocked blood vessel, which can make your vision blurry.
What is Aflibercept (Eylea)?
It's a medicine given by injection into the eye to help reduce fluid and swelling and improve vision in certain eye conditions.
Why is this study important?
It's testing if a new version of Eylea, or a different way of giving it, could be a better or more convenient treatment option for this eye condition.
Will I know if I'm getting the new medicine or the standard one?
No, this is a 'masked' study, meaning neither you nor your study doctor will know which treatment you are receiving until after the study is complete. This helps to ensure fair and unbiased results.
How long will the study last if I join?
If you participate, the study will involve follow-up for about 64 weeks, which is roughly 1 year and 3 months.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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