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)
Running, not enrolling
Conditions studied: Retinopathy of Prematurity
In brief
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.
Key facts
- Study ID
- NCT04515524
- Run by
- Regeneron Pharmaceuticals
- People needed
- 100
- Starts
- 2021-02-05
- Expected to finish
- 2026-11-05
- Last updated by the study team
- 2026-03-27
Who can join
Age: 1 and older, up to 5. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Patient has a condition preventing participation in the study, or performance of study procedures
- NOTE: Other Inclusion/Exclusion criteria may apply
Where it is running
- 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)
Full record on ClinicalTrials.gov
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