DUS ROP
Research type
Research Study
Full title
Drug utilisation study for Eylea (aflibercept) 40 mg/mL using the PICLEO paediatric dosing device in preterm infants with retinopathy of prematurity in the UK
IRAS ID
337368
Contact name
Rosie Gilbert,
Contact email
Sponsor organisation
Bayer
Duration of Study in the UK
3 years, 10 months, 3 days
Research summary
Retinopathy of prematurity (ROP) is a condition where the eyes of babies born very early stop developing properly, possibly causing vision problems or blindness. About 10-11% of babies are born prematurely, and ROP affects those born before 32 weeks. In Europe, the incidence varies. Most cases are mild and resolve on their own, but some may need treatment.
In the UK, around 300 ROP patients need treatment each year. Treatments include laser and injections to the eye. Guidelines suggest using anti-VEGF agents (used to stop the growth of new abnormal blood vessels in the eye, which often leak fluid or bleed) for specific ROP zones. The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK requested a study on the long-term safety of Eylea (aflibercept) 40mg/mL for treating ROP in a prefilled syringe (PFS), along with a specialized paediatric dosing device (PDD).
This observational retrospective data study will utilise data on Eylea PFS+PDD already collected into the National Neonatal Research Database. The first phase (around 12 months) of the study will be a drug utilisation study (DUS) to assess the number of infants treated with Eylea PFS+PDD. If such numbers are sufficiently high, this will allow progression to a longer-term safety study. This approach has been agreed with the MHRA as a condition of Eylea authorisation in the UK and is also part of the EU Risk Management Plan.
Assessing the number of infants exposed to Eylea PFS+PDD is crucial before planning a more extensive study on its long-term safety.
REC name
North East - York Research Ethics Committee
REC reference
24/NE/0043
Date of REC Opinion
15 Feb 2024
REC opinion
Favourable Opinion