Neovascular Age-related Macular Degeneration Clinical Trial
Official title:
An Open-label, Long-term, Safety and Tolerability Extension Study of Intravitreal VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration
The primary objective is to assess long-term safety and tolerability of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in patients with neovascular AMD.
The dose evaluated in this study, Intravitreal Aflibercept Injection (IAI; EYLEA®;
BAY86-5321) 2mg, will be the higher of the 2 dose strengths evaluated in parent study
VGFT-OD-0605 (NCT00509795) and is the dose level administered in study VGFT-OD-0702
(NCT00527423), a long-term open-label extension study. For these reasons, this dose has been
selected for this extension study.
Participants will be seen in the clinic for quarterly visits starting with day 1 to assess
safety. Study drug will be administered on an as-needed basis at the discretion of the
investigator with a minimum allowed interval of every 4 weeks and a maximum allowed interval
of every 12 weeks. This study will assess the frequency that re-treatment is needed and the
effect of continued Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) treatment
on BCVA.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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