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)

Launched by BAYER · Mar 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called aflibercept (Eylea) is used to treat a serious eye condition called retinopathy of prematurity (ROP) in preterm babies in the UK. ROP occurs when the retina, the part of the eye that helps us see, doesn’t develop properly in babies who are born too early. The trial will collect information about babies who are treated with aflibercept using a special dosing device that helps ensure they receive the correct amount of the medication safely. The main goals are to find out how many babies are being treated with this method and to see if there are enough cases to conduct a future study on the long-term safety of aflibercept for these infants.

To be eligible for this study, babies must have been born during the study period and diagnosed with ROP in at least one eye. They also need to have received care in a participating neonatal unit. Importantly, this study only involves collecting information from medical records; there are no additional visits or tests required from the babies or their families. The study will take place from March 2024 to March 2025, but it may continue until April 2027 if more data is needed.

Gender

ALL

Eligibility criteria

• 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.