This study will evaluate the efficacy, safety, and pharmacokinetics of RO6867461 when dosed every 8 weeks (Q8W) and with a personalized treatment interval (PTI) regimen compared with aflibercept (Eylea®) monotherapy in patients with diabetic macular edema (DME).
Macular thickening secondary to DME involving the center of the fovea with CST greater or equal to 325 µm
20/40 to 20/320 approximate Snellen equivalent
- Documented diagnosis of diabetes mellitus (Type 1 or Type 2), as defined by the American Diabetes Association or per WHO criteria and
- Current regular use of insulin for the treatment of diabetes and/or
- Current regular use of oral anti-hyperglycemic agents for the treatment of diabetes
- Currently untreated diabetes mellitus or previously untreated patients who initiated oral anti-diabetic medication or insulin within 3 months prior to Day 1
- History of allergy or hypersensitivity to active drug aflibercept and any of its excipients, fluorescein, or any study treatment-related mandatory ingredients that is not amenable to treatment
- High-risk proliferative diabetic retinopathy (PDR) in the study eye, using any of the following established criteria for high-risk PDR
The study will randomize patients with DME who are naive to anti-vascular endothelial growth factor (anti-VEGF) therapy in the study eye and patients who have previously been treated with anti-VEGF therapy in the study eye, provided that the last treatment was at least 3 months prior to the Day 1 visit (the first study treatment).
In addition to screening, you will have 26 study visits approximately every 4 weeks. After the first study treatment injection on Day 1, you will return to the clinic for a follow up visit on Day 7 (±3 days) for eye assessments.
Patients in all three treatment arms will complete scheduled study visits Q4W for the entire study duration (100 weeks). A sham procedure will be administered to patients in all three treatment arms at applicable visits to maintain masking among treatment arms.