High Dose (HD) Aflibercept Switch in Neovascular Age-related Macular Degeneration (nAMD): to Load or Maintain (HEIRLOOM)
This study, called HEIRLOOM, is looking into how best to switch patients from a common treatment for 'wet' age-related macular degeneration (AMD), EYLEA® (aflibercept 2mg), to a newer, higher-dose version, EYLEA® HD (aflibercept 8mg). While EYLEA® HD has been proven effective, we don't yet have enough information on the best way for patients already on EYLEA® to start taking the new medicine. The study will compare two different schedules for giving the EYLEA® HD injections to see which works better. It's a 'Phase 3' trial, which means it's a large study building on earlier research. About 180 adults with 'wet' AMD will take part, all of whom have already received regular EYLEA® treatment.
At a glance
What is this study about?
This study, known as HEIRLOOM, is focused on a common eye condition called 'wet' age-related macular degeneration, or 'wet' AMD. This condition can cause blurry vision or blind spots. We already have a good treatment called EYLEA®, which involves regular injections into the eye to help control the condition and protect your sight.
Recently, a new, stronger version of this medicine, EYLEA® HD, has become available. It's been shown to work well in studies with many patients and is designed to provide longer-lasting effects, meaning potentially fewer injections. However, those earlier studies mainly looked at patients who hadn't been treated for 'wet' AMD before.
The important question this study aims to answer is: what's the best way for patients who are already receiving regular EYLEA® to switch over to the new EYLEA® HD? Should they start with several frequent injections of the new medicine, or can they go straight to a less frequent schedule? By comparing different ways of giving EYLEA® HD to patients already using EYLEA®, the researchers hope to find the safest and most effective plan to help maintain their vision with the new treatment.
Key takeaways
- Tests EYLEA® HD, a new higher-dose medicine for 'wet' AMD.
- Compares two different schedules for starting EYLEA® HD.
- For patients already receiving standard EYLEA® treatment.
- Aims to find the best way to switch to the new drug.
- Could lead to fewer injections over time for patients.
- Study builds on previous research showing EYLEA® HD is effective.
Who may be eligible?
To be considered for this study, you need to be an adult, aged 18 or over, and have 'wet' age-related macular degeneration. A key requirement is that you must have already been receiving regular EYLEA® (2mg) injections for your 'wet' AMD. This means you would have had at least three initial injections, plus at least two more regular maintenance injections.
Your eye doctor will check if one or both of your eyes meet the study requirements. It's possible for you to join if only one of your eyes is suitable, or if both are.
There are some reasons why you wouldn't be able to join. For example, if you have other specific eye conditions that affect the macula (the central part of your vision), or if you've previously had certain other eye treatments like PDT or focal laser. You also can't be pregnant, or already taking part in another clinical study.
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?
- Do you have 'wet' age-related macular degeneration?
- Have you been having regular EYLEA® (2mg) injections for your condition?
- Do you have any other eye conditions, like polypoidal choroidal vasculopathy or a disciform scar?
- Are you currently pregnant or trying to get pregnant?
- Are you taking part in another medical study right now?
What does participation involve?
If you decide to take part in this study, you will be one of about 180 patients. The study involves switching from your current EYLEA® 2mg treatment to the new EYLEA® HD 8mg. You will be assigned to one of two groups, each receiving EYLEA® HD injections at a different schedule. This will help doctors compare which schedule works best for patients already on EYLEA®. You will have regular appointments at the clinic for your injections and check-ups. The total length of your participation would be determined during the screening process, but these studies usually last for a year or more with follow-up visits.
Potential risks and benefits
Locations (1)
- Clinique de Retine de L'EstVerified postcodeMontreal, Canada
Common questions
What is 'wet' AMD?
It's an eye condition that affects central vision, often causing blurriness or blind spots, due to leaky blood vessels under the retina.
What is EYLEA® HD?
It's a newer, stronger version of a common eye injection drug already used to treat 'wet' AMD. 'HD' stands for High Dose.
Why is this study needed?
We need to find the best and safest way for patients already on EYLEA® to switch to EYLEA® HD, as current guidelines are mainly for new patients.
Will I still get my EYLEA® if I don't join?
Yes, declining to participate in the study will not affect your access to your usual and recommended treatments.
Where is this study taking place?
This particular study is being conducted at the Clinique de Retine de l'Est in Montreal, Quebec, Canada.
How to find out more
Cynthia lacasse
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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