Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315556
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-02-26
Brief Title:
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
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Drug Utilization Study for Eylea 40 mgmL Using the PICLEO Paediatric Dosing Device in Preterm Infants With Retinopathy of Prematurity in the UK
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 babys 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 15 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
ROP is a condition that affects the eyes of preterm babies It occurs when the babys 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 15 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None