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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) | Clinical Trials | Clareo Health

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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)

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

NCT04515524•Regeneron Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 5 years

Sex

ALL

Healthy Volunteers

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

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

Key Dates

Start Date

February 5, 2021

Primary Completion Date

November 5, 2026

Completion Date

November 5, 2026

Last Updated

May 14, 2025

Enrollment

100

ACTUAL participants

Conditions

Retinopathy of Prematurity

Interventions

Non-Interventional

OTHER

An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)

NCT06315556

Retinopathy of PrematurityPreterm Infants

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RECRUITINGPHASE3

Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)

Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity

Impact of Standardized Skin-to-Skin Care on Clinical Outcomes in Infants Born ≤ 32 Weeks: A Multicenter Study

Safety and Efficacy of 18 mm Short Vitrectomy Probe for Pediatric Vitreoretinal Surgeries

Validation of i-ROP DL to Detect More Than Mild ROP

Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090