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
- Interventions
- Other: Non-Interventional
- 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
- Arm && Interventions
Group Intervention Description ROP patients from VGFTe-ROP-1920 Non-Interventional Retinopathy of prematurity (ROP) who were treated with aflibercept and/or laser photocoagulation in study VGFTe-ROP-1920.
- Primary Outcome Measures
Name Time Method Proportion of Patients with Serious Adverse Events Up to 5 years of chronological age Binocular best-corrected visual acuity (BCVA) 5 years of chronological age Proportion of Patients with Adverse Events Up to 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
๐น๐ญBangkok, Thailand
UCSD Shiley Eye Institute, Jacobs Retina Center
๐บ๐ธLa Jolla, California, United States
Loma Linda University Eye Institute
๐บ๐ธLoma Linda, California, United States
University of California San Francisco - Ophthalmology
๐บ๐ธSan Francisco, California, United States
New York University School of Medicine - Oncology
๐บ๐ธNew York, New York, United States
Icahn School of Medicine at Mount Sinai
๐บ๐ธNew York, New York, United States
University Hospitals Cleveland Medical Center
๐บ๐ธCleveland, Ohio, United States
Lifespan - Women & Infants Hospital of RI
๐บ๐ธProvidence, Rhode Island, United States
The Children's Hospital of San Antonio
๐บ๐ธSan Antonio, Texas, United States
West Virginia University
๐บ๐ธMorgantown, West Virginia, United States
Acibadem City Clinic Multiprofile Hospital for Active Treatment
๐ง๐ฌSofia, Bulgaria
Specialized Hospital for Active Treatment of Eye Diseases - Varna
๐ง๐ฌVarna, Bulgaria
Clinica Universitaria Bolivariana
๐จ๐ดMedellรญn, Antioquia, Colombia
Fundacion Oftalmologica de Santander Foscal
๐จ๐ดFloridablanca, Santander, Colombia
Soon Chun Hyang University Cheonan Hospital
๐ฐ๐ทCheonan, Chungcheongnam-do, Korea, Republic of
V.F. Voyno-Yasenetsky Scientific and Practical Center of Specialized Medical Care for Children - ophtalmology
๐ท๐บMoscow, Moskva, Russian Federation
SC Centrul Medical Unirea SRL
๐ท๐ดIasi, Romania
St. Petersburg State Pediatric Medical University - ophtalmology
๐ท๐บSaint-Petersburg, Russian Federation
Chung-Ho Memorial Hospital
๐จ๐ณKaohsiung, Taiwan
Chulalongkorn University
๐น๐ญBangkok, Krung Thep Maha Nakhon, Thailand
Phramongkutklao Hospital
๐น๐ญBangkok, Thailand
Eskisehir Osmangazi University Medical Faculty Hospital
๐น๐ทEskisehir, Turkey
Prince of Songkla University - Ophthalmology
๐น๐ญHat Yai, Songkhla, Thailand
Chiang Mai University
๐น๐ญChiang Mai, Thailand
Srinagarind Hospital - Ophthalmology
๐น๐ญKhon Kaen, Thailand
SBU Adana Sehir Training and Research Hospital
๐น๐ทAdana, Turkey
Hacettepe University Medical Faculty
๐น๐ทAnkara, Turkey
Gazi University Medical Faculty Hospital
๐น๐ทAnkara, Turkey
Children's Hospital 1 - Ophthalmology Unit
๐ป๐ณHo Chi Minh, Thanh Pho, Vietnam
Hue Central Hospital
๐ป๐ณHue, Thua Thien-Hue, Vietnam