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Retinopathy of prematurity, Preterm infants

Bayer Identifier:

22539

ClinicalTrials.gov Identifier:

NCT06315556

EudraCT Number:

Not Available

EU CT Number:

Not Available
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)

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

NaN - 1 Years
  • - 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.
  • - Infants with missing data for gestational age at birth will be excluded.

Trial summary

Enrollment Goal
200
Trial Dates
March 2024 - April 2027
Phase
N/A
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Many locationsMany locations, United Kingdom

Primary Outcome

  • Number of participants treated with Eylea PFS+PDD upon completion of 1- or 3-years following market introduction
    - To evaluate trends in drug utilization patterns of Eylea prefilled syringe (PFS)+Paediatric Dosing Device (PDD) in the ROP patient population. Exposure to Eylea is defined as a record of Eylea PFS+PDD in the National Neonatal Research Database (NNRD) database during admission to the neonatal unity during the study period. - To inform the decision on whether the number of preterm infants with ROP exposed to Eylea PFS+PDD is sufficient (n=200) for proceeding with a cohort study to collect data on long-term safety (ocular and systemic safety including neurodevelopmental outcome).
    date_rangeTime Frame:
    From market introduction of Eylea PFS+PDD in UK up to 3 years

Secondary Outcome

  • Summary of patient characteristics reported as number of participants with different categories
    Birth weight (in categories), sex, gestational age in weeks (in categories), ethnicity, etc.
    date_rangeTime 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
    Problems during pregnancy with mother, problems during pregnancy, mode of delivery, meconium stained liquor at delivery, etc.
    date_rangeTime 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
    Brain injury, necrotising enterocholitis, pulmonary hemorrhage, chronic lung disease, etc.
    date_rangeTime 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
    Respiratory support (mode of ventilation), cardiovascular (inotropic support), feeding (parenteral and enteral nutrition)
    date_rangeTime Frame:
    From market introduction of Eylea PFS+PDD in UK up to 3 years
  • Summary of clinical condition and resource utilization reported as days
    Intensive care days, invasive ventilation days, parenteral nutrition days
    date_rangeTime 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
    Survival to discharge from neonatal care (Y/N); Discharge, death, transferred to another hospital (in categories)
    date_rangeTime 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
    Number of Eylea injections in the neonatal unity, ROP surgery, ROP stage, ROP clock hours, ROP Max zone, etc.
    date_rangeTime Frame:
    From market introduction of Eylea PFS+PDD in UK up to 3 years

Trial design

Drug utilization study for Eylea 40 mg/mL using the PICLEO paediatric dosing device in preterm infants with retinopathy of prematurity in the UK
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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