Status:
RECRUITING
A Study to Collect Data on the Use of Eylea in Babies Born Too Early Who Have a Condition of the Eye Where Blood Vessels Grow Abnormally in the Retina (Retinopathy of Prematurity)
Lead Sponsor:
Bayer
Conditions:
Retinopathy of Prematurity
Newborns
Eligibility:
All Genders
Up to 2 years
Brief Summary
This is an observational study to collect data from Japanese babies with retinopathy of prematurity (ROP) who will be treated with Eylea. In observational studies, only observations are made without s...
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of ROP requiring treatment
- Patients who have received IVT-AFL treatment according to Japanese approved labeling for AFL in ROP.
- ICF obtained from legal representative.
Exclusion Criteria:
- Patients who have contradictions based on approved label
- Patients who have received IVT-AFL treatment before the treatment for the enrollment Patient.
- Diagnosis of other indication
Key Trial Info
Start Date :
March 27 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 30 2027
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05705258
Start Date
March 27 2023
End Date
March 30 2027
Last Update
March 31 2026
Active Locations (1)
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1
Many locations
Multiple Locations, Japan