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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)
Sponsor: Regeneron Pharmaceuticals
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.
Official title: An Extension Study to Evaluate the Long-Term Outcomes of Patients Who Received Treatment for Retinopathy of Prematurity in the VGFTe-ROP-1920 Study
Key Details
Gender
All
Age Range
11 Months - 5 Years
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2021-02-05
Completion Date
2026-11-05
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
Non-Interventional
No study treatment will be administered in this study
Locations (30)
UCSD Shiley Eye Institute, Jacobs Retina Center
La Jolla, California, United States
Loma Linda University Eye Institute
Loma Linda, California, United States
University of California San Francisco - Ophthalmology
San Francisco, California, United States
New York University School of Medicine - Oncology
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Lifespan - Women & Infants Hospital of RI
Providence, Rhode Island, United States
The Children's Hospital of San Antonio
San Antonio, Texas, United States
West Virginia University
Morgantown, West Virginia, United States
Acibadem City Clinic Multiprofile Hospital for Active Treatment
Sofia, Bulgaria
Specialized Hospital for Active Treatment of Eye Diseases - Varna
Varna, Bulgaria
Clinica Universitaria Bolivariana
Medellín, Antioquia, Colombia
Fundacion Oftalmologica de Santander Foscal
Floridablanca, Santander Department, Colombia
SC Centrul Medical Unirea SRL
Iași, Romania
V.F. Voyno-Yasenetsky Scientific and Practical Center of Specialized Medical Care for Children - ophtalmology
Moscow, Moscow, Russia
St. Petersburg State Pediatric Medical University - ophtalmology
Saint Petersburg, Russia
Soon Chun Hyang University Cheonan Hospital
Cheonan, Chungcheongnam-do, South Korea
Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Chulalongkorn University
Bangkok, Bangkok, Thailand
Prince of Songkla University - Ophthalmology
Hat Yai, Changwat Songkhla, Thailand
Phramongkutklao Hospital
Bangkok, Thailand
Queen Sirikit National Institute Of Child Health - Pediatrics
Bangkok, Thailand
Chiang Mai University
Chiang Mai, Thailand
Srinagarind Hospital - Ophthalmology
Khon Kaen, Thailand
SBU Adana Sehir Training and Research Hospital
Adana, Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, Turkey (Türkiye)
Gazi University Medical Faculty Hospital
Ankara, Turkey (Türkiye)
Eskisehir Osmangazi University Medical Faculty Hospital
Eskişehir, Turkey (Türkiye)
Children's Hospital 1 - Ophthalmology Unit
Ho Chi Minh City, Thanh Pho, Vietnam
Hue Central Hospital
Huế, Thừa Thiên Huế Province, Vietnam