Clinical Research Directory

Inclusion Criteria: * Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity * Age ≥18 years and ≤90 years old * Documented diagnosis of diabetes mellitus (type 1 or 2), as defined by the American Diabetes Association or per World Health Organization (WHO) criteria * Hemoglobin A1C (HbA1c) of ≤12% for ≤60 days before Day 1 * Macular thickening secondary to DME involving the center of the fovea with CST ≥325 μm on OCT as determined by the central reading center at the screening visit * Adequately clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images * BCVA of 73-25 ETDRS letters inclusive (20/40-20/200 approximate Snellen equivalent), using the ETDRS protocol at the initial testing distance of 4 m on Day 1 * Treatment naïve and previously treated participants with protocol specified drug washout Exclusion Criteria: * Be pregnant or breastfeeding * Active cancer within the past 12 months * Stroke (cerebral vascular accident) or myocardial infarction \<6 months before Day 1 * High risk proliferative diabetic retinopathy (PDR) in the study eye * Any treatment with panretinal photocoagulation or macular laser in the study eye * Any history of idiopathic or immune-mediated uveitis in either eye * Active ocular inflammation or suspected or active ocular or periocular infection in either eye on Day 1 * History of vitreoretinal surgery/pars plana vitrectomy, corneal transplant, or intraocular glaucoma surgery in the study eye * Any planned surgery in the study eye during the course of the study * Uncontrolled glaucoma * Renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis, or anticipated to require hemodialysis or peritoneal dialysis at any time during the trial Other inclusion and exclusion criteria may apply.