An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
This study is gathering information about how a medicine called aflibercept (Eylea) is used to treat premature babies in the UK with an eye condition called Retinopathy of Prematurity (ROP). ROP can affect a baby's eyesight if not treated. Aflibercept is given as an injection into the eye and helps stop abnormal blood vessel growth. Doctors use a special device to give the right amount of medicine safely. This study isn't about giving new treatment; it's about collecting existing data. Its main aims are to find out how many babies are being treated with aflibercept using this new method and whether there's enough information to do a larger study in the future looking at the medicine's long-term safety for ROP.
At a glance
What is this study about?
This important study is designed to understand more about how a medicine called aflibercept (also known as Eylea) is being used to treat a serious eye condition in premature babies across the UK. This eye condition is called Retinopathy of Prematurity, or ROP for short.
ROP affects babies who are born early, especially those born before 32 weeks or weighing less than 1.5 kilograms. In ROP, the tiny blood vessels at the back of the eye (the retina) don't develop properly. If not treated, this can lead to serious vision problems, including blindness. Aflibercept is a medicine that helps by blocking a protein in the eye that causes these abnormal blood vessels to grow. It's given as an injection into the baby's eye. For this particular treatment, doctors use a special prefilled syringe along with a 'paediatric dosing device' to make sure the babies receive the correct and safe amount of medicine.
The main goal of this study is not to test a new treatment, but to find out how many premature babies in the UK are currently being treated with aflibercept using this specific method. This information helps researchers understand how common this treatment approach is. Another key aim is to see if there are enough babies being treated this way to allow for a future, larger study that could look at the long-term safety of aflibercept for ROP. The study will also collect information about the babies receiving the treatment, such as their age, sex, and how their ROP symptoms developed. All this information comes from existing medical records, so no new tests or procedures are involved for the babies.
Key takeaways
- This study uses existing medical records to learn about ROP treatment.
- It focuses on premature babies treated with aflibercept (Eylea) for ROP in the UK.
- The main goal is to count how many babies receive this treatment and plan future safety studies.
- No new treatments, injections, or visits are involved for your baby if their data is included.
- The study helps understand ROP treatment patterns for better future care.
Who may be eligible?
This study is looking at information from babies who meet certain criteria. They need to have been born during the study period, which started around late 2023 and could go on until April 2027 depending on how much data is found.
The babies must have received care in a neonatal unit (a special care unit for newborns) in the UK that is part of a national research database. Also, the neonatal unit itself needs to agree to let their data be used for this study. Most importantly, the baby must have been diagnosed with Retinopathy of Prematurity (ROP) in at least one eye.
Babies might not be included if their birth details, like their gestational age (how many weeks pregnant mum was when they were born), are missing from their records.
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.
- My baby was born prematurely.
- My baby was diagnosed with Retinopathy of Prematurity (ROP).
- My baby received care in a UK neonatal unit that shares data with the national research database.
- My baby was treated with aflibercept (Eylea) for ROP.
What does participation involve?
Taking part in this study doesn't involve your baby having any extra visits to the hospital, tests, or treatments. This is because the study only uses existing information that has already been collected as part of your baby's routine care. Researchers will look at medical records from a national database (called the National Neonatal Research Database). The study will look at data from babies born from roughly late 2023 onwards. The data collection period could last until March 2025, or even April 2027 if more information is needed.
Potential risks and benefits
Locations (1)
- Many locationsUnverifiedMultiple Locations, United Kingdom· Recruiting
Common questions
What is Retinopathy of Prematurity (ROP)?
ROP is an eye condition that can affect babies born prematurely, where blood vessels in the back of the eye don't develop normally. It can sometimes lead to vision problems if not treated.
What is aflibercept (Eylea)?
Aflibercept is a medicine injected into the eye. It helps stop abnormal blood vessel growth in the retina that happens with ROP.
Will my baby get extra treatment or tests if they are in this study?
No, this study only uses existing medical records. Your baby will not have any extra treatments, tests, or appointments because of this study.
Why is this study being done?
The study aims to find out how many premature babies in the UK are being treated with aflibercept for ROP and to see if there's enough information to plan a future study looking at the long-term safety of this treatment.
How long will the study collect data for?
The study will collect data from records of babies born from late 2023. Data collection might continue until March 2025, or possibly extended until April 2027 if more information is needed.
How to find out more
Bayer Clinical Trials Contact
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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