Status:
RECRUITING
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)
Lead Sponsor:
Bayer
Conditions:
Retinopathy of Prematurity
Preterm Infants
Eligibility:
All Genders
Up to 1 years
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 ...
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.
Key Trial Info
Start Date :
March 5 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06315556
Start Date
March 5 2024
End Date
April 30 2027
Last Update
March 19 2026
Active Locations (1)
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1
Many locations
Multiple Locations, United Kingdom