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)
← catalyst calendarNCT04515524 · readout in 78 d
Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
—
Status
Active, not recruiting
Study type
Observational
Enrollment
100actual
Sites
30
Countries
Bulgaria, Colombia, Romania +7
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-02-05 | actual | When the study began enrolling |
| Primary completion | 2026-11-05 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-11-05 | estimated | The whole study's end, after follow-up |
| First posted | 2020-08-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-27 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Retinopathy of Prematurity
Intervention
- Other: Non-Interventional
Primary outcomes
what the primary-completion date above is the date OFBinocular best-corrected visual acuity (BCVA)
measured 5 years of chronological age
Proportion of Patients with Adverse Events
measured Up to 5 years of chronological age
Proportion of Patients with Serious Adverse Events
measured Up to 5 years of chronological age
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