Table 1. Study eye major inclusion and exclusion criteria.

Inclusion criteria

Best corrected E-ETDRS visual acuity letter score of ≤73 (approximate Snellen equivalent of 20/40 or worse) and ≥24 (approximate Snellen equivalent of 20/320 or better). [Note: the original upper limit of visual acuity letter score was expanded from ≤68 letters to ≤73 letters eight months after accrual began] Center-involved diabetic macular edema present on clinical examination Central subfield mean thickness (CST) of two OCT fast macular scans ≥250 microns Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs

Exclusion criteria

Presence of macular edema due to a cause other than diabetic macular edema Presence of an ocular condition such that visual acuity would not improve from resolution of the edema (e.g. foveal atrophy) Substantial cataract estimated to have reduced visual acuity by 3 lines or more Prior treatment with intravitreal corticosteroids at any time or peribulbar steroid injection within 6 months prior to randomization History of focal/grid macular photocoagulation within 15 weeks (3.5 months) or panretinal photocoagulation (PRP) within 4 months prior to randomization or anticipated need for PRP within the 4 months following randomization Prior pars plana vitrectomy Major ocular surgery (including cataract extraction) within prior 6 months or anticipated within the next 6 months following randomization YAG capsulotomy performed within 2 months prior to randomization Intraocular pressure (IOP) ≥25 mmHg, open-angle glaucoma (either primary open-angle glaucoma or other cause of open-angle glaucoma), steroid-induced IOP elevation that required IOP-lowering treatment or pseudoexfoliation Aphakia