firefleye

A randomized, 2-arm, open-label, phase 3 study to evaluate the efficacy, safety, and tolerability of intravitreal aflibercept versus laser photocoagulation in subjects with retinopathy of prematurity

10.10.2019 bis 31.12.2020

Currently available clinical data indicate potential advantages of the
use of IVT anti-VEGF agents, including aflibercept, compared to laser photocoagulation for treatment of ROP, and caused a gradual but steady increase in off-label use of IVT anti-VEGF agents in this condition. However, currently available prospective and longer-term data on the use of aflibercept for the treatment of ROP are still insufficient. The efficacy of IVT aflibercept in a well-characterized population of patients with ROP still needs to be evidenced by data from a prospective clinical trial. Knowledge of the benefit-risk profile for this population needs to be improved, and the pharmacokinetic parameters of aflibercept need to be more fully characterized taking into account the characteristics and limitations of this premature newborn population. These data are planned to be generated in a clinical development program including this randomized, phase 3, multicenter, 2-arm, open-label clinical study to assess the efficacy, safety, and tolerability of IVT aflibercept in subjects with ROP.