Japanese Safety Study of VEGF Trap-Eye in DME (Diabetic Macular Edema)

An Open-label Phase III Study Evaluating the Safety and Tolerability of Repeated Doses of Intravitreal VEGF Trap-Eye in Japanese Subjects With Diabetic Macular Edema

This study will assess the safety and tolerability of intravitreally (IVT) administered VEGF Trap-Eye in Japanese subjects with diabetic macular edema (DME) over the period of one year.

Inclusion Criteria:

• Adults ≥ 18 years with type 1 or 2 diabetes mellitus
• Subjects with DME (diabetic macular edema) secondary to diabetes mellitus involving the center of the macula in the study eye
• BCVA (best-corrected visual acuity) ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 24 (20/40 to 20/320) in the study eye

Exclusion Criteria:

• Active proliferative diabetic retinopathy (PDR) in the study eye
• Uncontrolled diabetes mellitus, as defined by HbA1c >12%
• Only 1 functional eye even if that eye is otherwise eligible for the study