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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)

Active, not recruiting
Conditions
Retinopathy of Prematurity
Registration Number
NCT04515524
Lead Sponsor
Regeneron Pharmaceuticals
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
100
Inclusion Criteria
  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
Exclusion Criteria
  1. Patient has a condition preventing participation in the study, or performance of study procedures

NOTE: Other Inclusion/Exclusion criteria may apply

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Proportion of Patients with Serious Adverse EventsUp to 5 years of chronological age
Proportion of Patients with Adverse EventsUp to 5 years of chronological age
Binocular best-corrected visual acuity (BCVA)5 years of chronological age
Secondary Outcome Measures
NameTimeMethod
BCVA in each eye3 year of chronological age, 5 years of chronological age
Neurodevelopmental outcomes using BSID-III2 years of chronological age

The Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) is a standard series of tests that will assess the development of children in 3 areas: cognition, language, and motor skills. This is a mandatory assessment to be performed at 2 years of age.

Neurodevelopmental outcomes using WPPSI-IV5 years of chronological age

The Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) is designed to assess development of older children and is recommended to be performed at 3, 4 and 5 years of age. The assessment at 5 years of age is mandatory. In cases where the WPSSI-IV cannot be used, the Differential Ability Scales II (DAS-II) may be used as an alternative.

Proportion of patients with recurrence of ROP3 years of chronological age, 5 years of chronological age
Proportion of patients requiring treatment for ROPThrough 5 years of chronological age
Proportion of patients developing unfavorable ocular structural outcome3 years of chronological age, 5 years of chronological age

Unfavorable ocular structural outcome: retinal detachment, macular dragging, macular fold, retrolental opacity

Refractive spherical equivalent in each eye3 years of chronological age, 5 years of chronological age
Neurodevelopmental outcomes using VABS-II2 years of chronological age, 5 years of chronological age

The Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Expanded Interview will be included, which includes 4 areas: Communication, Daily Living skills, Socialization and Motor Skills. The assessments at 2 years and 5 years of age are mandatory.

Trial Locations

Locations (30)

Queen Sirikit National Institute Of Child Health - Pediatrics

🇹🇭

Bangkok, Thailand

UCSD Shiley Eye Institute, Jacobs Retina Center

🇺🇸

La Jolla, California, United States

Loma Linda University Eye Institute

🇺🇸

Loma Linda, California, United States

University of California San Francisco - Ophthalmology

🇺🇸

San Francisco, California, United States

New York University School of Medicine - Oncology

🇺🇸

New York, New York, United States

Icahn School of Medicine at Mount Sinai

🇺🇸

New York, New York, United States

University Hospitals Cleveland Medical Center

🇺🇸

Cleveland, Ohio, United States

Lifespan - Women & Infants Hospital of RI

🇺🇸

Providence, Rhode Island, United States

The Children's Hospital of San Antonio

🇺🇸

San Antonio, Texas, United States

West Virginia University

🇺🇸

Morgantown, West Virginia, United States

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Queen Sirikit National Institute Of Child Health - Pediatrics
🇹🇭Bangkok, Thailand

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