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)
NCT ID: NCT04515524
Last Updated: 2025-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
100 participants
OBSERVATIONAL
2021-02-05
2026-11-05
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ROP patients from VGFTe-ROP-1920
Retinopathy of prematurity (ROP) who were treated with aflibercept and/or laser photocoagulation in study VGFTe-ROP-1920.
Non-Interventional
No study treatment will be administered in this study
Interventions
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Non-Interventional
No study treatment will be administered in this study
Eligibility Criteria
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Inclusion Criteria
2. Age \<13 months of chronological age
3. 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
11 Months
5 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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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
Countries
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Other Identifiers
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2020-005875-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-513231-24-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
VGFTe-ROP-2036
Identifier Type: -
Identifier Source: org_study_id
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