This study is accepting new patients by invitation only

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 study on Retinopathy of Prematurity Premature Birth

Summary

Eligibility
for people ages 11 months to 5 years (full criteria)
Location
at UCSD UCSF
Dates
study started
completion around

Description

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.

Official Title

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

Keywords

Retinopathy of Prematurity, Retinal Diseases, Premature Birth, Non-Interventional

Eligibility

You can join if…

Open to people ages 11 months to 5 years

  1. Patient was treated in study VGFTe-ROP-1920
  2. Age <13 months of chronological age
  3. Signed informed consent from parent(s)/legal guardian(s), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

You CAN'T join if...

  1. Patient has a condition preventing participation in the study, or performance of study procedures

NOTE: Other Inclusion/Exclusion criteria may apply

Locations

  • UCSD Shiley Eye Institute, Jacobs Retina Center
    La Jolla California 92093-0946 United States
  • University of California San Francisco - Ophthalmology
    San Francisco California 94158 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Regeneron Pharmaceuticals
ID
NCT04515524
Study Type
Observational
Participants
Expecting 112 study participants
Last Updated