Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090

Study Overview
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Brief Summary
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This is a follow-up study to evaluate the long term outcome of babies treated in the FIREFLEYE study.

Official Title
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An Extension Study to Evaluate the Long-term Outcomes of Subjects Who Received Treatment for Retinopathy of Prematurity in Study 20090

Conditions
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Retinopathy of Prematurity (ROP)

Intervention / Treatment
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* Drug: Eylea (Aflibercept, BAY86-5321)
* Procedure: Laser photocoagulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject was treated in Study 20090 Age less than 13 months of chronological age Signed informed consent from parent(s)/legally authorized representative(s), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol Exclusion Criteria: - Subject has a condition preventing participation in the study, or performance of study procedures.

Ages Eligible for Study
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Maximum Age: 13 Months

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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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aflibercept arm<br>No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090. | Drug: Eylea (Aflibercept, BAY86-5321)<br>* Treatment administered in 20090. Solution in a sterile glass vial, Dose A, IVT injection.<br>|
| Active Comparator: Laser photocoagulation arm<br>No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090. | Procedure: Laser photocoagulation<br>* Treatment administered in 20090. Transpupillary conventional laser ablative therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular best-corrected visual acuity in Snellen equivalent |  | At 5 years of age. | 
| Proportion of subjects with ocular AEs and SAEs | AE: adverse event SAE: serious adverse event | Up to 5 years of age. | 
| Proportion of subjects with systemic AEs and SAEs |  | Up to 5 years of age. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects developing unfavorable ocular structural outcome | Unfavorable ocular structural outcome include: retinal detachment, macular dragging, macular fold, retrolental opacity | At 1,3 and 5 years of age. | 
| Proportion of subjects with absence of active ROP and unfavorable structural outcomes |  | At 1 year of age. | 
| Best-corrected visual acuity in each eye |  | At 3 and 5 years of age. | 
| Refractive spherical equivalent in each eye |  | At 3 and 5 years of age | 
| Neurodevelopmental outcomes using BSID-III | 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. It is recommended to be assessed at screening, 1 year and 2 years of age. The assessment at 2 years of age is mandatory. | At 2 years of age | 
| Neurodevelopmental outcomes using WPPSI-IV | WPPSI-IV: The Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition 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. | At 5 years of age | 
| Neurodevelopmental outcomes using VABS-II | VABS-II: Vineland Adaptive Behavior Scales, Second Edition Expanded Interview will be included, which includes 4 areas: Communication, Daily Living skills, Socialization and Motor Skills. It is recommended to be assessed at 2, 3, 4 and 5 years of age. The assessments at 2 years and 5 years of age are mandatory. | At 2 and 5 years of age | 
| Proportion of subjects with recurrence of ROP |  | At 3 and 5 years of age. | 
| Proportion of subjects requiring treatment for ROP |  | Up to 5 years of age. | 
| Proportion of subjects requiring ophthalmological treatment |  | Up to 5 years of age. |