🏛️ Verified NIH Record • Updated 2026-03-25

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)

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

🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Regeneron Pharmaceuticals

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: UCSD Shiley Eye Institute, Jacobs Retina Center — La Jolla, California

Age range: 11 Months to 5 Years

🧪 Interventions in This Study

  • Non-Interventional (OTHER)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (30 Sites)

Showing the first 25 of 30 sites.

  • UCSD Shiley Eye Institute, Jacobs Retina Center — La Jolla, California
  • Loma Linda University Eye Institute — Loma Linda, California
  • University of California San Francisco - Ophthalmology — San Francisco, California
  • New York University School of Medicine - Oncology — New York, New York
  • Icahn School of Medicine at Mount Sinai — New York, New York
  • University Hospitals Cleveland Medical Center — Cleveland, Ohio
  • Lifespan - Women & Infants Hospital of RI — Providence, Rhode Island
  • The Children's Hospital of San Antonio — San Antonio, Texas
  • West Virginia University — Morgantown, West Virginia
  • Acibadem City Clinic Multiprofile Hospital for Active Treatment — Sofia,
  • Specialized Hospital for Active Treatment of Eye Diseases - Varna — Varna,
  • Clinica Universitaria Bolivariana — Medellín, Antioquia
  • Fundacion Oftalmologica de Santander Foscal — Floridablanca, Santander Department
  • SC Centrul Medical Unirea SRL — Iași,
  • V.F. Voyno-Yasenetsky Scientific and Practical Center of Specialized Medical Care for Children - ophtalmology — Moscow, Moscow
  • St. Petersburg State Pediatric Medical University - ophtalmology — Saint Petersburg,
  • Soon Chun Hyang University Cheonan Hospital — Cheonan, Chungcheongnam-do
  • Chung-Ho Memorial Hospital — Kaohsiung City,
  • Chulalongkorn University — Bangkok, Bangkok
  • Prince of Songkla University - Ophthalmology — Hat Yai, Changwat Songkhla
  • Phramongkutklao Hospital — Bangkok,
  • Queen Sirikit National Institute Of Child Health - Pediatrics — Bangkok,
  • Chiang Mai University — Chiang Mai,
  • Srinagarind Hospital - Ophthalmology — Khon Kaen,
  • SBU Adana Sehir Training and Research Hospital — Adana,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Retinopathy of Prematurity

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗