This study is in progress, not accepting new patients

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)

Description

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.

An Extension Study to Evaluate the Long-Term Outcomes of Patients Who Received Treatment for Retinopathy of Prematurity in the VGFTe-ROP-1920 Study

Open to people ages 11 months to 5 years

Patient was treated in study VGFTe-ROP-1920
Age <13 months of chronological age
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

Patient has a condition preventing participation in the study, or performance of study procedures

NOTE: Other Inclusion/Exclusion criteria may apply