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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)

Recruitingn/aAges any - 1 YearAllBayer
NCT06315556 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is an observational study in which only data from babies with retinopathy of prematurity (ROP) who are being treated with aflibercept (Eylea) in prefilled syringe (PFS) using a paediatric dosing device (PDD) are collected and studied. ROP is a condition that affects the eyes of preterm babies. It occurs when the baby's retina, the part of the eye that senses light, does not develop normally. This may result in vision problems, including blindness, if left untreated. Preterm babies are born before 37 weeks of pregnancy. ROP is more likely to develop in babies who are born before 32 weeks of pregnancy or weigh less than 1.5 kilograms at birth. Aflibercept is a drug that is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth of blood vessels in the retina. Aflibercept in PFS given using a PDD is approved

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📋 Eligibility rules (as published)
Inclusion Criteria: * Eligible infants within the NNRD include those who were: * 1\. Born during the study period, i.e. from Q4/2023 following market introduction of Eylea PFS+PDD and 31st December 2026, and * 2\. Received care in a neonatal unit that contributes data to the NNRD and the unit has agreed to participate in the study, and * 3\. Diagnosed with ROP in any stage in at least one eye. Exclusion Criteria: * Infants with missing data for gestational age at birth will be excluded.
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What it tests

  • Aflibercept (Eylea)
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Where

1 site
Many locations
Multiple Locations, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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