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Study identifier: NCT06315556 Synced from ClinicalTrials.gov · July 29, 2026
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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)

Condition: Retinopathy of Prematurity · Preterm Infants  ·  Sponsor: Bayer

PhaseN/A
Planned participants200
Who can joinAll sexes, N/A to 1 Year
Healthy volunteersNo

About this study

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 for the treatment of babies with ROP. The prefilled syringe will be fitted with an injection needle to give aflibercept. And a PDD is a tool used to give the right amount of aflibercept to children in a safe manner. Since there are other treatments which are commonly used for babies with ROP, the extent of use of aflibercept given using a PDD is unknown. The main purpose of this study is to: * find the number of preterm babies who are treated with aflibercept using a PDD in the UK * inform whether this number is enough to perform a study to learn about the long-term safety of aflibercept g…

This description comes directly from the study's public registry record.

Talk to the study team

Bayer Clinical Trials Contact  ·  (+)1-888-84 22937  ·  clinical-trials-contact@bayer.com

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Locations (1)

Many locationsMultiple Locations, United KingdomRecruiting

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Source record: clinicaltrials.gov/study/NCT06315556