A Multi-center, Single-arm, Interventional Phase 4 Study to Evaluate a Treat and Extend Regimen of Intravitreal Aflibercept for Treatment of Macular Edema Secondary to Central Retinal Vein Occlusion

Central retinal vein occlusion (CRVO) occurs when the main blood vessel that transports blood
away from the retina (the very back portion of the eye) becomes blocked, causing the leakage
of fluid into the retina and thereby causing a swelling of the macula (the portion of the
retina responsible for fine vision). This swelling is called macular edema. When the macula
swells with fluid, central vision becomes blurry. The study drug aflibercept has been shown
to reduce the amount of fluid and blood leaked into the retina. It can help to stabilize, and
in many cases, improve the vision loss related to CRVO. Aflibercept has been approved for the
treatment of macular edema secondary to CRVO in the United States (US), European Union (EU),
Japan, and other countries.

The study was considered research because, although the study drug was already on the market
for macular edema secondary to CRVO, there were no studies available that addressed the
questions of what were useful intervals for treating and assessing patients, how did they
differ among patients, and how were criteria applied for retreatment. The purpose of this
study was to evaluate the effectiveness, treatment interval, and safety of the treatment
regimen (pattern for administering treatment) in subjects with macular edema secondary to
CRVO. In addition, this study explored new imaging methods for assessing the affected eye.