Drug Utilization Study for Eylea 40 mg/mL Using the PICLEO Paediatric Dosing Device in Preterm Infants With Retinopathy of Prematurity in the UK

What this Trial Is About

Researchers are conducting an observational study to collect data on preterm babies with retinopathy of prematurity (ROP) who are treated with aflibercept (Eylea) delivered using a paediatric dosing device (PDD). ROP affects the eyes of preterm infants, especially those born before 32 weeks or weighing less than 1.5 kilograms, potentially leading to vision problems. The study aims to find out how many babies in the UK receive this treatment and to describe their characteristics and ROP symptoms. The treatment being studied is aflibercept, a drug injected into the eye to block abnormal blood vessel growth caused by ROP. It is given using a prefilled syringe combined with a paediatric dosing device to ensure safe and accurate dosing. The study collects data from babies treated with this method recorded in the National Neonatal Research Database from March 2024 to March 2025, or until April 2027 if more data is needed. Participants are not required to attend any visits or undergo tests for this study since only existing data from the database is used. Researchers will measure the number of babies treated with aflibercept using the PDD and summarize their characteristics, maternal factors, comorbidities, clinical conditions, resource use, outcomes, and ocular treatment details. The study will review data for up to three years following the drug's market introduction in the UK.

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)