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)
NCT ID: NCT06315556
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
200 participants
OBSERVATIONAL
2024-03-05
2027-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
Aflibercept (Eylea)
Eylea 40 mg/mL solution for injection in pre-filled syringe.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Aflibercept (Eylea)
Eylea 40 mg/mL solution for injection in pre-filled syringe.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
1 Year
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bayer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Many locations
Multiple Locations, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
Click here for access to information about Bayer's transparency standards and Bayer studies
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
22539
Identifier Type: -
Identifier Source: org_study_id