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

The following is an abbreviated list of inclusion criteria:

- Adults between 18 to 80 years of age, inclusive

- Diagnosis of diabetes mellitus (type 1 or type 2)

- Decrease in vision in the study eye determined to be primarily the result of DME

- Definite retinal thickening due to diffuse DME involving the central macula in the
study eye

- Central subfield thickness of at least 325 µm by sdOCT with presence of intraretinal
fluid in the study eye

- ETDRS BCVA letter score ≤ 76 and ≥ 24 in the study eye

The following is an abbreviated list of exclusion criteria:

- 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