Hemoglobin A1C (HbA1C) ≥ 12.0% at Screening

History of non infectious uveitis

Decrease in visual acuity due to causes other than DME in the study eye

History of any of the following in the study eye (however, the following are not exclusionary in the fellow eye):

1. Prior pars plana vitrectomy

2. Any ocular surgery within 3 months prior to Day 1

3. YAG capsulotomy within 3 months prior to Day 1

4. Panretinal scatter photocoagulation (PRP) or focal laser within 3 months prior to Day 1 or anticipated need for PRP during the course of the study

5. Prior intravitreal, subtenon, or periocular steroid therapy within 3 months prior to Day 1

6. Prior treatment with intravitreal anti-vascular endothelial growth factor (VEGF) treatment within 8 weeks prior to Day 1

The TIME-2 Study: A Phase 2 Study of AKB-9778, a Novel Tie-2 Activator, in Patients With Diabetic Macular Edema