Retinopathy of PrematurityNCT06315556
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)
An observational study of Retinopathy of Prematurity and Preterm Infants, run by Bayer at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Retinopathy of Prematurity, Preterm Infants
- What is being tested?
- Aflibercept (Eylea)
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Mar 2024to 30 Apr 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 year
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Infants with missing data for gestational age at birth will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Many locations
Multiple Locations
About this study
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
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.
Read more
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.
- Conditions
- Retinopathy of Prematurity, Preterm Infants
- Being tested
- Aflibercept (Eylea)
- Keywords
- ROP
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept (Eylea)Drug
Eylea 40 mg/mL solution for injection in pre-filled syringe.
| Study group | Role | What they receive |
|---|---|---|
| Premature infants diagnosed with ROP | Premature infants diagnosed with retinopathy of prematurity (ROP) and treated with aflibercept 0.4 mg using the Eylea 40 mg/mL prefilled syringe (PFS) in combination with the PICLEO paediatric dosing device (PDD) after marketing authorisation in UK and included in the National Neonatal Research Database (NNRD). Receives: Drug: Aflibercept (Eylea) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From market introduction of Eylea PFS+PDD in UK up to 3 years
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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.
Measured: From market introduction of Eylea PFS+PDD in UK up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start5 Mar 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315556
- Sponsor's protocol ID
- 22539
- Status last verified
- Oct 2026
- First submitted
- 26 Feb 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.