Single-arm, open label, multicenter clinical study to evaluate the handling and safety of AVT06 pre-filled syringe (PFS) in subjects with chorioretinal vascular disease followed by an optional extension phase of AVT06 pre-filled syringe (PFS).
This important study is investigating a new, simpler way to administer injections for various serious eye conditions that affect your central vision, such as wet macular degeneration (nAMD), diabetic macular edema (DME), and problems from diabetes or vein blockages in the eye (RVO, DR). The main goal is to test a pre-filled syringe containing the eye medicine aflibercept. Researchers want to see if this new syringe is easy for doctors and nurses to use and if it's safe for patients. In particular, they'll check how often injections are successfully given and if there are any side effects. This is a late-stage study (Phase III), meaning the medicine has already shown promise, and they're now confirming its practical use and safety in a real-world setting.
At a glance
What is this study about?
This study is focused on improving how people receive treatments for several eye conditions that can seriously affect their vision. These conditions, such as wet macular degeneration (nAMD), diabetic macular edema (DME), and certain complications of diabetes or blocked eye veins, all involve abnormal blood vessel changes at the back of the eye. These changes can lead to fluid leaking and swelling, causing blurry or distorted vision.
The main treatment for these conditions often involves regular injections of medicine directly into the eye. This study is looking at a specific medicine called aflibercept. The key innovation here is a new, pre-filled syringe (PFS) for delivering aflibercept. The goal is to see if this pre-filled syringe makes the injection process easier and more consistent for healthcare professionals, and just as safe for patients as the current method.
Researchers will closely monitor how often the injections are given successfully using this new syringe. They will also pay very close attention to any side effects, particularly those affecting the eye, to ensure the new delivery method is safe. If successful, this could mean a more streamlined and potentially more comfortable treatment experience for patients in the future.
Key takeaways
- This study is testing a new, pre-filled syringe for an existing eye medicine (aflibercept).
- It's for people with common sight-threatening eye conditions like wet macular degeneration or diabetic eye disease.
- The main goals are to see how easy and safe the new syringe is to use for eye injections.
- This is a late-stage study, meaning the medicine is already established, and they are refining its delivery.
- Participants would receive eye injections and have regular eye check-ups.
Who may be eligible?
To be considered for this study, you would generally need to be an adult, 18 years old or older. The study is open to both men and women.
More importantly, you would need to have one of the specific eye conditions that the study is investigating. These include 'wet' age-related macular degeneration (nAMD), diabetic macular edema (swelling in the eye due to diabetes, called DME), myopic choroidal neovascularization (CNV, a condition linked to severe short-sightedness), retinal vein occlusion (RVO, a blocked vein in the eye), or diabetic retinopathy (DR, eye damage from diabetes).
The medical team would review your health history and perform eye exams to make sure you fit all the detailed requirements for joining the study. There will also be specific criteria to make sure the study includes the right people to answer the research questions, and these would be discussed with you.
- Are you 18 years old or older?
- Do you have a diagnosis of 'wet' age-related macular degeneration (nAMD)?
- Or do you have diabetic macular edema (DME) or diabetic retinopathy (DR)?
- Or do you have myopic choroidal neovascularization (CNV) or retinal vein occlusion (RVO)?
- Are you able to attend regular clinic visits for eye checks and injections?
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, your participation would begin with an initial screening visit to confirm you meet all the study requirements. Once enrolled, you would receive the study medication, aflibercept, using the new pre-filled syringe. This would involve injections into your eye, as is standard practice for your condition.
The study would involve regular visits to the clinic. At these visits, doctors and nurses would perform eye examinations, check your vision, and monitor for any changes or side effects. They would also keep track of how easily the injections are given using the new syringe. The study has an initial phase to evaluate the new syringe, and then an optional longer extension phase, during which you could continue to receive the treatment. The total duration of your involvement, including the number of visits and injections, would be clearly explained by the study team.
Potential risks and benefits
Locations (1)
- —Latvia
Common questions
What is aflibercept?
Aflibercept is a medicine commonly used to treat several eye conditions that cause vision loss by stopping abnormal blood vessel growth and fluid leakage in the eye.
What does 'pre-filled syringe' mean?
A pre-filled syringe means the medicine is already loaded into the syringe by the manufacturer, which can make it easier and more consistent for medical staff to prepare and give the injection.
What are 'ocular TEAEs'?
This stands for 'ocular treatment-emergent adverse events,' which just means any medical problems or side effects that happen in the eye after the treatment starts.
Is this a new medicine?
No, aflibercept itself is not a new medicine. This study is looking at a new way to deliver it using a pre-filled syringe, rather than the medicine itself being new.
How long will the study last?
The study has an initial assessment phase followed by an optional longer treatment phase. The exact total duration for you would be discussed if you are eligible.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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