Clinical trial NCT06315556: 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)
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Retinopathy of Prematurity
Preterm Infants
Keywords: ROP
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2024-03-18
Enrollment: 200
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All premature infants diagnosed with ROP and treated with Eylea PFS + PDD included in the National Neonatal Research Database (NNRD) during the study period in the UK.

Brief summary: 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.


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.

Primary outcomes:
measure: Number of participants treated with Eylea PFS+PDD upon completion of 1- or 3-years following market introduction
timeFrame: From market introduction of Eylea PFS+PDD in UK up to 3 years
Secondary outcomes:
measure: Summary of patient characteristics reported as number of participants with different categories
timeFrame: From market introduction of Eylea PFS+PDD in UK up to 3 years
measure: Summary of maternal factors reported as number of participants with different categories
timeFrame: From market introduction of Eylea PFS+PDD in UK up to 3 years
measure: Summary of comorbidities reported as number of participants with different categories
timeFrame: From market introduction of Eylea PFS+PDD in UK up to 3 years
measure: Summary of clinical condition and resource utilization reported as number of participants with different categories
timeFrame: From market introduction of Eylea PFS+PDD in UK up to 3 years
measure: Summary of clinical condition and resource utilization reported as days
timeFrame: From market introduction of Eylea PFS+PDD in UK up to 3 years
measure: Summary of outcomes of the premature infants reported as number of participants with different categories
timeFrame: From market introduction of Eylea PFS+PDD in UK up to 3 years
measure: Summary of ocular disease and treatment reported as number of participants with different categories
timeFrame: From market introduction of Eylea PFS+PDD in UK up to 3 years
Other outcomes:
Locations:
city: Multiple Locations
country: United Kingdom
facility: Many locations
Study officials:
References: