A single center, 12 month pilot study randomizing 40 DME eyes from 30 subjects 1:1 to BCZ plus adjunctive DEX implant (i.e., BCZ (1.25 mg) at baseline and then monthly when retreatment criteria was met except at months 5 and 10 when DEX implant (0.7 mg) was administered 0.7 mg) or BCZ (1.25 mg monthly) demonstrated similar mean vision gains (+4.9 ± 12.3 ETDRS letters vs. +5.4 ± 10.7 ETDRS letters) but more effective resolution of central subfield thickness (30 ± 100 µm vs. 45 ± 107 µm) with the combination regimen (Maturi RK, 2013; ClinicalTrials.gov Identifier: NCT01309451 http://clinicaltrials.gov/ct2/show/record/NCT01309451). We estimate that a final sample size of at least 20 eyes per study arm is required. Assuming a third of the study eyes may be lost to follow-up we will require enrolment of 30 eyes per study arm.