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)

Study Overview
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Brief Summary
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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.

Official Title
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An Extension Study to Evaluate the Long-Term Outcomes of Patients Who Received Treatment for Retinopathy of Prematurity in the VGFTe-ROP-1920 Study

Conditions
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Retinopathy of Prematurity

Intervention / Treatment
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* Other: Non-Interventional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 1. Patient has a condition preventing participation in the study, or performance of study procedures NOTE: Other Inclusion/Exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 11 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ROP patients from VGFTe-ROP-1920<br>Retinopathy of prematurity (ROP) who were treated with aflibercept and/or laser photocoagulation in study VGFTe-ROP-1920. | Other: Non-Interventional<br>* No study treatment will be administered in this study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients developing unfavorable ocular structural outcome | Unfavorable ocular structural outcome: retinal detachment, macular dragging, macular fold, retrolental opacity | 3 years of chronological age, 5 years of chronological age | 
| 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 | 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. | 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. | 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. | 2 years of chronological age, 5 years of chronological age | 
| 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 |