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ACTIVE NOT RECRUITING

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 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • OTHER Non-Interventional

Study Locations (20)

Other

  • Acibadem City Clinic Multiprofile Hospital for Active Treatment — Sofia
  • Specialized Hospital for Active Treatment of Eye Diseases - Varna — Varna
  • SC Centrul Medical Unirea SRL — Iași
  • St. Petersburg State Pediatric Medical University - ophtalmology — Saint Petersburg
  • Chung-Ho Memorial Hospital — Kaohsiung City

California

  • UCSD Shiley Eye Institute, Jacobs Retina Center — La Jolla
  • Loma Linda University Eye Institute — Loma Linda
  • University of California San Francisco - Ophthalmology — San Francisco

New York

  • New York University School of Medicine - Oncology — New York
  • Icahn School of Medicine at Mount Sinai — New York

Ohio

  • University Hospitals Cleveland Medical Center — Cleveland

Rhode Island

  • Lifespan - Women & Infants Hospital of RI — Providence

Texas

  • The Children's Hospital of San Antonio — San Antonio

West Virginia

  • West Virginia University — Morgantown

Antioquia

  • Clinica Universitaria Bolivariana — Medellín

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2021-02-05
Est. Completion 2026-11-05

Sponsor

Regeneron Pharmaceuticals

290 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04515524

The ClinicalTrials.gov registry entry for NCT04515524 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 290 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Retinopathy of Prematurity appearing as the primary indexed condition, and to 1 intervention — of which Non-Interventional is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04515524 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, California, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04515524 about?

NCT04515524 is a clinical study titled "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)". 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 ...

What is the current status of trial NCT04515524?

This trial is currently active not recruiting. The enrollment target is 100 participants. The study started on 2021-02-05. Estimated completion is 2026-11-05.

What conditions does trial NCT04515524 study?

This clinical trial studies the following conditions: Retinopathy of Prematurity. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04515524?

The interventions under investigation include: Non-Interventional (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04515524?

This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04515524 being conducted?

This trial has 20 study locations across California, New York, Ohio, Rhode Island, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial