Participants

This prospective study enrolled 20 eyes of 20 patients between December 2015 and August 2017 that demonstrated foveal involving retinal edema secondary to DR. Inclusion and exclusion criteria are outlined in the previously published 6-month results analysis. Briefly, inclusion criteria specified that participants have spectral-domain OCT (SD-OCT), CST greater than or equal to 325 µm, Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA of 80 (20/25) to 20 (20/400), and history of previous intravitreal treatment with bevacizumab or ranibizumab with at least 4 previous injections in the last 6 months in the study eye. No patients had steroid injections in the 1 year prior to enrollment.

Pertinent exclusion criteria included patients who had any prior or concomitant therapy with another investigational agent to treat DME in the study eye, prior history of IAI, history of vitrectomy or panretinal photocoagulation in the study eye within 3 months, or previous intravitreal anti-VEGF therapy in the study eye within 30 days of enrollment. Epiretinal membranes were not considered an exclusion.

Only 1 eye per participant was enrolled in the study. If a nonstudy eye required treatment of DME at study entry or during participation in the study, the fellow eye could receive any anti-VEGF agent including IAI at the investigators’ discretion, but it was not considered an additional study eye. The frequency and course of fellow-eye treatment was based on investigators’ discretion.