A PHASE III MULTICENTER RANDOMIZED DOUBLE-MASKED ACTIVE COMPARATOR CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RO6867461 IN PATIENTS WITH DIABETIC MACULAR EDEMA (RHINE)

Brief description of study

The purpose of this study is to compare the effects, good or bad, RO6867461 has in comparison to aflibercept. In this study, the participant will get either RO6867461 or aflibercept. Aflibercept (Eylea®) is approved by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan for the treatment of DME and is considered one of the current standard-of-care medications for this eye disease. RO6867461 is an experimental drug, which means health authorities have not approved RO6867461 for the treatment of DME outside of a clinical trial. Prior to this study, RO6867461 had been tested in approximately 436 people with either DME or another eye disease known as neovascular age-related macular degeneration (nAMD; often referred to as wet AMD). DME is a chronic eye disease that can occur in people with diabetes and causes problems in vision, such as blurred or wavy vision, and colors that appear to be washed out.


Clinical Study Identifier: s18-00623
ClinicalTrials.gov Identifier: NCT03622593
Principal Investigator: Yasha S Modi.


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