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)

An Extension Study to Evaluate the Long-Term Outcomes of Patients Who Received Treatment for Retinopathy of Prematurity in the VGFTe-ROP-1920 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Retinopathy of Prematurity
• Intervention / Treatment: Other: Non-Interventional

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1407
    • Acibadem City Clinic Multiprofile Hospital for Active Treatment
  • Varna, Bulgaria, 9002
    • Specialized Hospital for Active Treatment of Eye Diseases - Varna
• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia, 050034
      • Clínica Universitaria Bolivariana
  • Santander Department
    • Floridablanca, Santander Department, Colombia, 681004
      • Fundacion Oftalmologica de Santander FOSCAL
• Romania
  • Iași, Romania, 700023
    • SC Centrul Medical Unirea SRL
• Russia
  • Saint Petersburg, Russia, 194100
    • St. Petersburg State Pediatric Medical University - ophtalmology
  • Moscow
    • Moscow, Moscow, Russia, 119620
      • V.F. Voyno-Yasenetsky Scientific and Practical Center of Specialized Medical Care for Children - ophtalmology
• South Korea
  • Chungcheongnam-do
    • Cheonan, Chungcheongnam-do, South Korea, 31151
      • Soon Chun Hyang University Cheonan Hospital
• Taiwan
  • Kaohsiung City, Taiwan, 80756
    • Chung-Ho Memorial Hospital
• Thailand
  • Bangkok, Thailand, 10400
    • Phramongkutklao Hospital
  • Bangkok, Thailand, 10400
    • Queen Sirikit National Institute Of Child Health - Pediatrics
  • Chiang Mai, Thailand, 50200
    • Chiang Mai University
  • Khon Kaen, Thailand, 4002
    • Srinagarind Hospital - Ophthalmology
  • Bangkok
    • Bangkok, Bangkok, Thailand, 10330
      • Chulalongkorn University
  • Changwat Songkhla
    • Hat Yai, Changwat Songkhla, Thailand, 90110
      • Prince of Songkla University - Ophthalmology
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 4522
    • SBU Adana Sehir Training and Research Hospital
  • Ankara, Turkey (Türkiye), 06230
    • Hacettepe University Medical Faculty
  • Ankara, Turkey (Türkiye), 06560
    • Gazi University Medical Faculty Hospital
  • Eskişehir, Turkey (Türkiye), 26480
    • Eskisehir Osmangazi University Medical Faculty Hospital
• United States
  • California
    • La Jolla, California, United States, 92093-0946
      • UCSD Shiley Eye Institute, Jacobs Retina Center
    • Loma Linda, California, United States, 92354
      • Loma Linda University Eye Institute
    • San Francisco, California, United States, 94158
      • University of California San Francisco - Ophthalmology
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10016
      • New York University School of Medicine - Oncology
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Lifespan - Women & Infants Hospital of RI
  • Texas
    • San Antonio, Texas, United States, 78240
      • The Children's Hospital of San Antonio
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University
• Vietnam
  • Thanh Pho
    • Ho Chi Minh City, Thanh Pho, Vietnam, 70000
      • Children's Hospital 1 - Ophthalmology Unit
  • Thừa Thiên Huế Province
    • Huế, Thừa Thiên Huế Province, Vietnam, 530000
      • Hue Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 1 year (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients who were treated in the VGFTe-ROP-1920 study are eligible for enrollment into this follow-up study.

Description

Inclusion Criteria:

1. Patient was treated in study VGFTe-ROP-1920
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:

1. Patient has a condition preventing participation in the study, or performance of study procedures

NOTE: Other Inclusion/Exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ROP patients from VGFTe-ROP-1920; Retinopathy of prematurity (ROP) who were treated with aflibercept and/or laser photocoagulation in study VGFTe-ROP-1920.	Other: Non-Interventional; No study treatment will be administered in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Binocular best-corrected visual acuity (BCVA)	5 years of chronological age
Proportion of Patients with Adverse Events	Up to 5 years of chronological age
Proportion of Patients with Serious Adverse Events	Up to 5 years of chronological age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients developing unfavorable ocular structural outcome	Unfavorable ocular structural outcome: retinal detachment, macular dragging, macular fold, retrolental opacity	3 years of chronological age, 5 years of chronological age
BCVA in each eye		3 year of chronological age, 5 years of chronological age
Refractive spherical equivalent in each eye		3 years of chronological age, 5 years of chronological age
Neurodevelopmental outcomes using BSID-III	The Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) is a standard series of tests that will assess the development of children in 3 areas: cognition, language, and motor skills. This is a mandatory assessment to be performed at 2 years of age.	2 years of chronological age
Neurodevelopmental outcomes using WPPSI-IV	The Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) is designed to assess development of older children and is recommended to be performed at 3, 4 and 5 years of age. The assessment at 5 years of age is mandatory. In cases where the WPSSI-IV cannot be used, the Differential Ability Scales II (DAS-II) may be used as an alternative.	5 years of chronological age
Neurodevelopmental outcomes using VABS-II	The Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Expanded Interview will be included, which includes 4 areas: Communication, Daily Living skills, Socialization and Motor Skills. The assessments at 2 years and 5 years of age are mandatory.	2 years of chronological age, 5 years of chronological age
Proportion of patients with recurrence of ROP		3 years of chronological age, 5 years of chronological age
Proportion of patients requiring treatment for ROP		Through 5 years of chronological age

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2021
• Primary Completion (Estimated): November 5, 2026
• Study Completion (Estimated): November 5, 2026

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 14, 2020
• First Posted (Actual): August 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infant, Premature, Diseases; Infant, Newborn, Diseases; Eye Diseases; Retinal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Retinopathy of Prematurity
• Other Study ID Numbers: VGFTe-ROP-2036; 2020-005875-10 (EudraCT Number); 2024-513231-24-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

IPD Sharing Time Frame

When Regeneron has:

• received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
• made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
• the legal authority to share the data, and
• ensured the ability to protect participant privacy

• IPD Sharing Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No