NCT04515524

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 11 Months – 5 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Non-Interventional	No study treatment will be administered in this study

Timeline

• Start date: 2021-02-05
• Primary completion: 2026-11-05
• Completion: 2026-11-05
• First posted: 2020-08-17
• Last updated: 2026-03-27

Locations

30 sites across 10 countries: United States, Bulgaria, Colombia, Romania, Russia, South Korea, Taiwan, Thailand, Turkey (Türkiye), Vietnam

Regulatory

• FDA-regulated drug study