Extension Study to Evaluate the Long-Term Outcomes of Pediatric Patients Who Received Treatment for Retinopathy of Prematurity in the VGFTe-ROP-1920 Study (Acronym: Butterfleye Next)

ID#: NCT04515524

Age: 11 months - 5 years

Gender: All

Healthy Subjects: No

Recruitment Status: Enrolling by invitation

Start Date: February 16, 2021

End Date: November 04, 2026

Summary: Primary objectives of the study are: - To evaluate binocular visual acuity at the end of this study in patients included from the VGFTe-ROP-1920 study, for treatment of Retinopathy of Prematurity (ROP). - To evaluate long-term safety outcomes in patients included from the VGFTe-ROP-1920 study, for treatment of ROP. Secondary objectives of the study are: - To describe visual function in patients included from the VGFTe-ROP-1920 study, for treatment of ROP. - To describe overall development in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.
Eligibility:

Inclusion Criteria:

1. Patient was treated in study VGFTe-ROP-1920

2. Age <13 months of chronological age

3. Signed informed consent from parent(s)/legal guardian(s), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Exclusion Criteria:

1. Patient has a condition preventing participation in the study, or performance of study procedures NOTE: Other Inclusion/Exclusion criteria may apply
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