Observational Study of Aflibercept Eylea Using a Pediatric Dosing Device for Treating Retinopathy of Prematurity in Preterm Babies in the UK

What this Trial Is About

This observational study collects data from preterm babies with retinopathy of prematurity ROP who are treated with aflibercept Eylea using a paediatric dosing device PDD. ROP affects the retina in premature infants, especially those born before 32 weeks gestation or weighing less than 1.5 kilograms, and may lead to vision problems or blindness if untreated. The study aims to understand how many babies in the UK receive aflibercept with this dosing device and to evaluate if this number is sufficient for future safety studies. Participants are preterm infants diagnosed with ROP who receive aflibercept 0.4 mg via an Eylea prefilled syringe combined with the PICLEO paediatric dosing device. This drug blocks abnormal blood vessel growth in the retina by targeting vascular endothelial growth factor VEGF. Data are collected from the National Neonatal Research Database covering babies born from March 2024 to March 2025 or until April 2027 if more data are needed. Since this is an observational study, no additional visits or tests are required beyond routine care. Researchers will review existing data on participant characteristics such as age, sex, race, maternal factors, clinical conditions, and treatment outcomes. The main outcome measures include the number of babies treated with aflibercept using the PDD and summaries of their clinical and ocular conditions over up to three years after market introduction.

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)