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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aflibercept (Eylea).
- Who it may be relevant to
- Registry conditions: Retinopathy of Prematurity, Preterm Infants. Basic parameters: up to 1 year · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Drug Utilization Study for Eylea 40 mg/mL Using the PICLEO Paediatric Dosing Device in Preterm Infants With Retinopathy of Prematurity in the UK
Overview
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 given using a PDD in babies with ROP An additional purpose of this study is to describe characteristics including age, sex, and race, and signs and symptoms of ROP observed in babies being treated with aflibercept using a PDD. The data will come from a database called the National Neonatal Research Database. The study will cover the period from March 2024 to March 2025, if the number of babies found is enough to perform the safety study. If not, data will be collected till April 2027. In this study only available data from preterm babies born during the study period are collected. No visits or tests are required as part of this study.
Interventions
- Drug Aflibercept (Eylea)
Eylea 40 mg/mL solution for injection in pre-filled syringe.
Primary outcome measures
- Number of participants treated with Eylea PFS+PDD upon completion of 1- or 3-years following market introduction [Time frame: From market introduction of Eylea PFS+PDD in UK up to 3 years]
Secondary outcome measures (7)
- Summary of patient characteristics reported as number of participants with different categories [Time frame: From market introduction of Eylea PFS+PDD in UK up to 3 years]
- Summary of maternal factors reported as number of participants with different categories [Time frame: From market introduction of Eylea PFS+PDD in UK up to 3 years]
- Summary of comorbidities reported as number of participants with different categories [Time frame: From market introduction of Eylea PFS+PDD in UK up to 3 years]
- Summary of clinical condition and resource utilization reported as number of participants with different categories [Time frame: From market introduction of Eylea PFS+PDD in UK up to 3 years]
- Summary of clinical condition and resource utilization reported as days [Time frame: From market introduction of Eylea PFS+PDD in UK up to 3 years]
- Summary of outcomes of the premature infants reported as number of participants with different categories [Time frame: From market introduction of Eylea PFS+PDD in UK up to 3 years]
- Summary of ocular disease and treatment reported as number of participants with different categories [Time frame: From market introduction of Eylea PFS+PDD in UK up to 3 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- Many locations — Multiple Locations
Identifiers
NCT: NCT06315556 · 22539