Efficacy and Safety of VEGF Trap Eye in Diabetic Macular Edema (DME) With Central Involvement

A Randomized, Double Masked, Active Controlled, Phase III Study of the Efficacy and Safety of Repeated Doses of Intravitreal VEGF Trap Eye in Subjects With Diabetic Macular Edema

To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in subjects with diabetic macular edema (DME) with central involvement.

Inclusion Criteria:

• Adults ≥ 18 years with type 1 or 2 diabetes mellitus
• Subjects with diabetic macular edema (DME) secondary to diabetes mellitus involving the center of the macula in the study eye
• Decrease in vision determined to be primarily the result of DME in the study eye
• Best-corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score of 73 to 24 (20/40 to 20/320) in the study eye

Exclusion Criteria:

• Laser photocoagulation (panretinal or macular) in the study eye within 90 days of Day 1
• More than 2 previous macular laser treatments in the study eye
• Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of Day 1
• Previous treatment with antiangiogenic drugs in either eye (pegaptanib sodium, bevacizumab, ranibizumab etc.) within 90 days of Day 1
• 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