firefleye next

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

10.10.2019 bis 31.12.2025

Data assessing the efficacy, safety, tolerability, and systemic exposure
to aflibercept versus laser photocoagulation in subjects with ROP will be generated in Study 20090, a phase 3, multicenter, 2-arm study. All treated patients from Study 20090 must be offered participation in a follow-up study 20275 until they are 5 years of age to assess ocular effects, clinical and neurodevelopmental outcomes. Subjects will be followed until the age of
5 years, when detailed assessment of visual function and overall development becomes feasible and stable. No study treatment is planned. In case any treatment for recurrence of ROP is required, subjects will be allowed to receive treatment according to the local standard of care.