Status:
ACTIVE_NOT_RECRUITING
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)
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Retinopathy of Prematurity
Eligibility:
All Genders
11-5 years
Brief 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 (RO...
Eligibility Criteria
Inclusion
- 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
- 1\. Patient has a condition preventing participation in the study, or performance of study procedures
- NOTE: Other Inclusion/Exclusion criteria may apply
Key Trial Info
Start Date :
February 5 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 5 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04515524
Start Date
February 5 2021
End Date
November 5 2026
Last Update
May 14 2025
Active Locations (30)
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1
UCSD Shiley Eye Institute, Jacobs Retina Center
La Jolla, California, United States, 92093-0946
2
Loma Linda University Eye Institute
Loma Linda, California, United States, 92354
3
University of California San Francisco - Ophthalmology
San Francisco, California, United States, 94158
4
New York University School of Medicine - Oncology
New York, New York, United States, 10016