Retinopathy of Prematurity
Conditions
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.
Interventions
OTHERNon-Interventional
No study treatment will be administered in this study
Sponsors
Regeneron Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
11 Months to 5 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Binocular best-corrected visual acuity (BCVA) | 5 years of chronological age |
| Proportion of Patients with Adverse Events | Up to 5 years of chronological age |
| Proportion of Patients with Serious Adverse Events | Up to 5 years of chronological age |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| BCVA in each eye | 3 year of chronological age, 5 years of chronological age | — |
| Refractive spherical equivalent in each eye | 3 years 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. |
| 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. |
| 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 | — |
Countries
Bulgaria, Colombia, Romania, Russia, South Korea, Taiwan, Thailand, Turkey (Türkiye), United States, Vietnam
Contacts
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed