DME And VEGF Trap-Eye [Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)] INvestigation of Clinical Impact

Inclusion Criteria: * Patients with clinically significant DME with central involvement * Adults 18 years or older with type 1 or 2 diabetes mellitus with diabetic macular edema * ETDRS BCVA: 20/40 to 20/320 (letter score of 73 to 24) in the study eye Exclusion Criteria: * History of vitreoretinal surgery in the study eye * Panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening * Previous use of intraocular or periocular corticosteroids in the study eye within 3 months of screening * Previous treatment with anti-angiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc) within 3 months of screening * Uncontrolled diabetes mellitus * Uncontrolled hypertension defined as systolic \> 180mmHg or \> 160 mmHg on 2 consecutive measurements or diastolic \> 100 mmHg on optimal medical regimen * Ocular disorders in the study eye, other than DME, that may confound interpretation of study results