Collecting data on the use of Aflibercept in preterm babies with eye condition
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 study is looking at how well Aflibercept works for treating eye problems in preterm babies with retinopathy of prematurity by collecting information from hospitals across the UK.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | N/A to 1 Year |
| Sex | All |
| Sponsor | Bayer Industry-sponsored |
| Locations | 1 site (Multiple Locations) |
| Trial ID | NCT06315556 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather data on preterm infants diagnosed with retinopathy of prematurity (ROP) who are treated with Aflibercept (Eylea) using a pediatric dosing device. The study will collect information from neonatal units across the UK that participate in the National Neonatal Research Database (NNRD). By focusing on infants born during a specific period and receiving care in participating units, the study seeks to understand the application and outcomes of this treatment in a vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants diagnosed with ROP who are receiving treatment with Aflibercept in participating neonatal units.
Not a fit: Patients who do not have ROP or those who were not treated with Aflibercept will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of Aflibercept's effectiveness and safety in treating ROP in preterm infants, potentially improving patient outcomes.
How similar studies have performed: While this study focuses on a specific treatment and population, similar observational studies have shown success in understanding treatment outcomes in preterm infants with ROP.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Multiple Locations
- Many locations — Multiple Locations, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Bayer Clinical Trials Contact
- Email: clinical-trials-contact@bayer.com
- Phone: (+)1-888-84 22937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.