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)

Launched by BAYER · Jan 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called Eylea in babies who were born prematurely and have a condition called retinopathy of prematurity (ROP). ROP is an eye problem that can occur when blood vessels in the retina, the part of the eye that helps us see, grow in an unhealthy way. While many babies with ROP recover without treatment, some need help to prevent serious issues, including vision loss. The trial is looking to gather information on how safe and effective Eylea is for these babies when used in real-life situations.

To participate in this study, babies must be diagnosed with ROP that requires treatment and have been prescribed Eylea by their doctors. Parents or guardians will be asked to provide consent for their baby's participation. Over a period of six months, the study will involve three routine check-ups where doctors will monitor the babies' health and track any side effects or improvements in their condition. This research will help doctors understand how well Eylea works and its safety for treating ROP in premature infants.

Gender

ALL

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