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NCT04515524 · ClinicalTrials.gov registry record
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)
A clinical trial of Retinopathy of Prematurity, sponsored by Regeneron Pharmaceuticals.
- Active
- Registry status
- 100
- Enrollment target
- 20
- Study locations
NCT04515524: Active study of Retinopathy of Prematurity, sponsored by Regeneron Pharmaceuticals.
NCT04515524 is a study of Retinopathy of Prematurity that is active but no longer recruiting, run by Regeneron Pharmaceuticals. The registered enrollment target is 100 participants, below the 355-participant average among 7 other Retinopathy of Prematurity trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04515524, a study of Retinopathy of Prematurity, is active but no longer recruiting, sponsored by Regeneron Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- 100 participants
- Enrollment target
- 20
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-02-05 |
| Est. Completion | 2026-11-05 |
What the registry record for NCT04515524 still lists
NCT04515524 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 355-participant average among 7 other Retinopathy of Prematurity trials with a reported enrollment target (72% lower).
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.
NCT04515524 names 20 study sites across 13 states, led by Other, California, New York.
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.
What interventions are being tested in trial NCT04515524?
The interventions under investigation include: Non-Interventional (OTHER).
Who is sponsoring clinical trial NCT04515524?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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.
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