An Extension Study to Evaluate the Long-Term Outcomes of Patients Who Received Treatment for Retinopathy of Prematurity in the VGFTe-ROP-1920 Study
Retinopathy of prematurity (ROP) is an eye condition that affects some babies born very early. It causes fragile blood vessels to grow abnormally in the eye, which can harm eyesight if not treated. In an earlier clinical trial, a group of babies received an injection of a medicine called Eylea to protect their sight. This extension study checks in on these same children as they grow older. Doctors want to understand how their vision develops, check that their eyes are growing normally, and make sure there are no delayed side effects. Researchers will also look at how the children learn, talk, and move using standard childhood development checks. By following these children over several years, doctors hope to learn how well this treatment protects eyesight throughout childhood and into school age.
At a glance
What is this study about?
When babies are born very early, the tiny blood vessels in the back of their eyes (the retina) have not finished growing. Sometimes, abnormal blood vessels start to grow instead, causing a condition called retinopathy of prematurity (ROP). If left untreated, this can cause scarring or even lead to severe sight loss. A medicine called Eylea (aflibercept) is used to slow down this abnormal vessel growth and help the eye heal.
In an earlier study, premature babies were treated with this medicine. Now, this follow-up study invites those same children back as they get older. Doctors want to see how their vision has developed over time, whether their eyes have grown into healthy shapes, and whether they need glasses or any further eye care.
The study also looks at the bigger picture of each child's health and learning. Growing up after a very premature birth can sometimes bring extra challenges. The study team will carry out gentle, play-based assessments to check physical movement, language, and problem-solving skills.
By keeping track of these children over several years, doctors can gather vital information about the long-term safety and success of the treatment. This will help doctors provide the best possible care for premature babies in the future.
Key takeaways
- A long-term follow-up study for children treated for ROP in an earlier trial.
- Monitors eyesight, eye growth, and overall childhood development over several years.
- Open only to families who took part in the previous VGFTe-ROP-1920 study.
- Involves routine, non-invasive eye exams and gentle, game-based development tests.
- Completely voluntary with no changes to your child's usual NHS rights.
Who may be eligible?
This study is only open to children who were enrolled and treated in the earlier trial, known as the VGFTe-ROP-1920 study. Both boys and girls can take part.
Because this is a long-term follow-up study, it is not suitable for children who did not take part in that original trial. Children must have received their initial care and study checks as premature infants within the previous project.
Parents or legal guardians must be willing and able to bring their child to the hospital clinic for scheduled eye examinations and developmental check-ups over the course of the 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.
- My child was enrolled in the earlier VGFTe-ROP-1920 clinical trial for ROP.
- My child received care or treatment during that previous study.
- I am happy to bring my child to scheduled hospital visits for vision and growth checks.
- I am comfortable with the study team tracking my child's progress over the next few years.
What does participation involve?
Taking part in this study does not involve new experimental medicine. Instead, it involves regular follow-up visits to an eye clinic as your child grows.
During clinic appointments, eye doctors will test how clearly your child can see (using picture charts or letter games) and check how their eyes focus. The doctor will also look inside the eyes to confirm that the retina is healthy and well-formed. Specialist staff will carry out gentle childhood development checks. These involve simple games, puzzles, and questions about how your child communicates and moves at home. Parents will also complete short questionnaires about their child's daily habits and milestones.
Visits are spread out over several years to coincide with key stages of childhood. The study team will arrange appointments to fit around your family's routine as much as possible.
Potential risks and benefits
Locations (2)
- —UnverifiedRomania
- —UnverifiedBulgaria
Common questions
Will my child need to have more eye injections?
No. This extension study is designed to monitor your child's development and eye health. Injections are not part of the study visits, though normal care will be provided if any eye problem ever needs treating.
Are the developmental tests stressful for young children?
Not at all. The developmental checks are designed like fun play sessions with puzzles, blocks, and pictures. They are led by trained staff who ensure the child feels comfortable and happy throughout.
How long will our family be involved in the study?
The study follows children through their early years to see how their vision develops as they reach school age. Your study doctor will explain the exact visit schedule.
Do we have to pay to take part?
No, taking part in clinical research is free. In most cases, study sites can also help with reasonable travel or parking expenses for study visits.
What happens if we want to leave the study?
You are free to stop participating at any time. Leaving the study will never affect the relationship you have with your child's doctors or the quality of their NHS care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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