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)
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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
EXCLUSION CRITERIA
Exclusion Criteria:
1. Patient has a condition preventing participation in the study, or performance of study procedures
NOTE: Other Inclusion/Exclusion criteria may apply
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Retinopathy of Prematurity
Age (in years)
11 - 5
Participants needed
100
Est. Completion Date
Nov 5, 2026
Treatment type
OBSERVATIONAL
Sponsor
Regeneron Pharmaceuticals
ClinicalTrials.gov identifier
NCT04515524
Study number
VGFTe-ROP-2036
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?