(20275) An extension study to evaluate the long-term outcomes of subjects who received treatment for retinopathy of prematurity in Study 20090

Retinopathy of prematurity

Binocular best-corrected visual acuity in Snellen equivalent score at 5 years of age.

Proportion of subjects with ocular adverse events (AEs) and serious AEs (SAEs) through 5 years of age, Proportion of subjects with systemic AEs and SAEs through 5 years of age, Proportion of subjects developing unfavorable ocular structural outcome (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 at 2 and 5 years of age using standardized development tests (eg, Bayley Scales of Infant and Toddler Development, Third Edition [BSID-III], the Differential Ability Scales® II [DAS-II®], the Wechsler Preschool and Primary Scale of Intelligence™, Fourth Edition [WPSSI-IV], Vineland Adaptive Behavior Scales, Second Edition [VABS-II])., Proportion of subjects with recurrence of ROP at 3 and 5 years of age, Proportion of subjects requiring treatment for ROP during this extension study, Proportion of subjects requiring ophthalmological treatment during this extension study

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