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)
| NCT ID | NCT06315556 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bayer |
| Condition | Retinopathy of Prematurity |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-03-05 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-03-05 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06315556 clinical trial?
This trial is open to participants of all sexes, up to 1 Year, studying Retinopathy of Prematurity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06315556 currently recruiting?
Yes, NCT06315556 is actively recruiting participants. Contact the research team at clinical-trials-contact@bayer.com for enrollment information.
Where is the NCT06315556 trial being conducted?
This trial is being conducted at Multiple Locations, United Kingdom.
Who is sponsoring the NCT06315556 clinical trial?
NCT06315556 is sponsored by Bayer. The trial plans to enroll 200 participants.