The TIME-2b Study: A Study of AKB-9778, a Novel Tie 2 Activator, in Patients With Non-Proliferative Diabetic Retinopathy (NPDR)

Key Inclusion Criteria:

- Adults 18 through 80 years of age (inclusive)

- Subjects with moderate to very severe NPDR (ETDRS Level 43 - 53 inclusive)

- No evidence of central involved DME

- ETDRS BCVA letter score ≥ 70 (Snellen 20/40 or better)

Key Exclusion Criteria:

- Ocular disease other than DR that may cause substantial reduction in visual acuity,
including iris neovascularization, retinal detachment, visually significant epiretinal
membrane, vitreous hemorrhage or fibrosis, ocular inflammation (uveitis), other
retinal inflammatory or infectious diseases

- Evidence of neovascularization on clinical examination or imaging

- Hemoglobin A1C (HbA1C) ≥ 12.0% at Screening

- Severe acute or chronic medical or psychiatric condition or laboratory abnormality
that may increase the risk associated with study participation