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)

NCT04515524 | Active Not Recruiting FDA Drug

• 3 other identifiers: VGFTe-ROP-20362020-005875-102024-513231-24-00
• Study Type: observational
• Target: 100
• Locations: 10 countries
• Sites: 30

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 (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.

Conditions

Retinopathy of Prematurity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Proportion of patients developing unfavorable ocular structural outcome

  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

  2 years of chronological age

• Neurodevelopmental outcomes using WPPSI-IV

  5 years of chronological age

Study Arms (1)

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

Interventions

Non-Interventional OTHER

No study treatment will be administered in this study

ROP patients from VGFTe-ROP-1920

Eligibility Criteria

• Age: 11 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (30)

UCSD Shiley Eye Institute, Jacobs Retina Center

La Jolla, California, 92093-0946, United States

Location

Loma Linda University Eye Institute

Loma Linda, California, 92354, United States

Location

University of California San Francisco - Ophthalmology

San Francisco, California, 94158, United States

Location

New York University School of Medicine - Oncology

New York, New York, 10016, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Lifespan - Women & Infants Hospital of RI

Providence, Rhode Island, 02905, United States

Location

The Children's Hospital of San Antonio

San Antonio, Texas, 78240, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Acibadem City Clinic Multiprofile Hospital for Active Treatment

Sofia, 1407, Bulgaria

Location

Specialized Hospital for Active Treatment of Eye Diseases - Varna

Varna, 9002, Bulgaria

Location

Clinica Universitaria Bolivariana

Medellín, Antioquia, 050034, Colombia

Location

Fundacion Oftalmologica de Santander Foscal

Floridablanca, Santander Department, 681004, Colombia

Location

SC Centrul Medical Unirea SRL

Iași, 700023, Romania

Location

V.F. Voyno-Yasenetsky Scientific and Practical Center of Specialized Medical Care for Children - ophtalmology

Moscow, Moscow, 119620, Russia

Location

St. Petersburg State Pediatric Medical University - ophtalmology

Saint Petersburg, 194100, Russia

Location

Soon Chun Hyang University Cheonan Hospital

Cheonan, Chungcheongnam-do, 31151, South Korea

Location

Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

Location

Chulalongkorn University

Bangkok, Bangkok, 10330, Thailand

Location

Prince of Songkla University - Ophthalmology

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Phramongkutklao Hospital

Bangkok, 10400, Thailand

Location

Queen Sirikit National Institute Of Child Health - Pediatrics

Bangkok, 10400, Thailand

Location

Chiang Mai University

Chiang Mai, 50200, Thailand

Location

Srinagarind Hospital - Ophthalmology

Khon Kaen, 4002, Thailand

Location

SBU Adana Sehir Training and Research Hospital

Adana, 4522, Turkey (Türkiye)

Location

Hacettepe University Medical Faculty

Ankara, 06230, Turkey (Türkiye)

Location

Gazi University Medical Faculty Hospital

Ankara, 06560, Turkey (Türkiye)

Location

Eskisehir Osmangazi University Medical Faculty Hospital

Eskişehir, 26480, Turkey (Türkiye)

Location

Children's Hospital 1 - Ophthalmology Unit

Ho Chi Minh City, Thanh Pho, 70000, Vietnam

Location

Hue Central Hospital

Huế, Thừa Thiên Huế Province, 530000, Vietnam

Location

MeSH Terms

Conditions

Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 17, 2020
• Study Start: February 5, 2021
• Primary Completion (Estimated): November 5, 2026
• Study Completion (Estimated): November 5, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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
• 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

Locations

RO (1); CO (2); US (9); TH (6); VN (2); TU (4); BU (2); TW (1); KR (1); RU (2)