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.
Study Type
OBSERVATIONAL
Enrollment
100
No study treatment will be administered in this study
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
Binocular best-corrected visual acuity (BCVA)
Time frame: 5 years of chronological age
Proportion of Patients with Adverse Events
Time frame: Up to 5 years of chronological age
Proportion of Patients with Serious Adverse Events
Time frame: Up to 5 years of chronological age
Proportion of patients developing unfavorable ocular structural outcome
Unfavorable ocular structural outcome: retinal detachment, macular dragging, macular fold, retrolental opacity
Time frame: 3 years of chronological age, 5 years of chronological age
BCVA in each eye
Time frame: 3 year of chronological age, 5 years of chronological age
Refractive spherical equivalent in each eye
Time frame: 3 years of chronological age, 5 years of chronological age
Neurodevelopmental outcomes using BSID-III
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.
Time frame: 2 years of chronological age
Neurodevelopmental outcomes using WPPSI-IV
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.
Time frame: 5 years of chronological age
Neurodevelopmental outcomes using VABS-II
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.
Time frame: 2 years of chronological age, 5 years of chronological age
Proportion of patients with recurrence of ROP
Time frame: 3 years of chronological age, 5 years of chronological age
Proportion of patients requiring treatment for ROP
Time frame: Through 5 years of chronological age
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Acibadem City Clinic Multiprofile Hospital for Active Treatment
Sofia, Bulgaria
...and 20 more locations