En observasjonsstudie for å samle inn data om hvordan Aflibercept (Eylea) gitt ved bruk av en pediatrisk doseringsenhet brukes til premature babyer med retinopati av prematuritet i Storbritannia (UK)
Studie av legemiddelbruk for Eylea 40 mg/ml ved bruk av PICLEO pediatrisk doseringsenhet hos premature spedbarn med retinopati hos prematuriteter i Storbritannia
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Bayer Clinical Trials Contact
- Telefonnummer: 0018888422937
- E-post: clinical-trials-contact@bayer.com
Studiesteder
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-
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Many Locations, Storbritannia
- Rekruttering
- Many locations
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: CROSS_SECTIONAL
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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). |
Eylea 40 mg/mL solution for injection in pre-filled syringe. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of participants treated with Eylea PFS+PDD upon completion of 1- or 3-years following market introduction
Tidsramme: From market introduction of Eylea PFS+PDD in UK up to 3 years
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From market introduction of Eylea PFS+PDD in UK up to 3 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Summary of patient characteristics reported as number of participants with different categories
Tidsramme: From market introduction of Eylea PFS+PDD in UK up to 3 years
|
Birth weight (in categories), sex, gestational age in weeks (in categories), ethnicity, etc. |
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
Tidsramme: From market introduction of Eylea PFS+PDD in UK up to 3 years
|
Problems during pregnancy with mother, problems during pregnancy, mode of delivery, meconium stained liquor at delivery, etc. |
From market introduction of Eylea PFS+PDD in UK up to 3 years
|
|
Summary of comorbidities reported as number of participants with different categories
Tidsramme: From market introduction of Eylea PFS+PDD in UK up to 3 years
|
Brain injury, necrotising enterocholitis, pulmonary hemorrhage, chronic lung disease, etc. |
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
Tidsramme: From market introduction of Eylea PFS+PDD in UK up to 3 years
|
Respiratory support (mode of ventilation), cardiovascular (inotropic support), feeding (parenteral and enteral nutrition) |
From market introduction of Eylea PFS+PDD in UK up to 3 years
|
|
Summary of clinical condition and resource utilization reported as days
Tidsramme: From market introduction of Eylea PFS+PDD in UK up to 3 years
|
Intensive care days, invasive ventilation days, parenteral nutrition days |
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
Tidsramme: From market introduction of Eylea PFS+PDD in UK up to 3 years
|
Survival to discharge from neonatal care (Y/N); Discharge, death, transferred to another hospital (in categories) |
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
Tidsramme: From market introduction of Eylea PFS+PDD in UK up to 3 years
|
Number of Eylea injections in the neonatal unity, ROP surgery, ROP stage, ROP clock hours, ROP Max zone, etc. |
From market introduction of Eylea PFS+PDD in UK up to 3 years
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 22539
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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.
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