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)
- 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
- Patient was treated in study VGFTe-ROP-1920
- Age <13 months of chronological age
- 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
- 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
Name Time Method Proportion of Patients with Serious Adverse Events Up to 5 years of chronological age Proportion of Patients with Adverse Events Up to 5 years of chronological age Binocular best-corrected visual acuity (BCVA) 5 years of chronological age
- Secondary Outcome Measures
Name Time Method BCVA in each eye 3 year of chronological age, 5 years of chronological age Neurodevelopmental outcomes using BSID-III 2 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-IV 5 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 ROP 3 years of chronological age, 5 years of chronological age Proportion of patients requiring treatment for ROP Through 5 years of chronological age Proportion of patients developing unfavorable ocular structural outcome 3 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 eye 3 years of chronological age, 5 years of chronological age Neurodevelopmental outcomes using VABS-II 2 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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