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RHINE


Title A Phase Ill, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of RO6867461 in Patients with Diabetic Macular Edema (RHINE) 
Therapeutic Area Diabetic Eye Problems
Principal Investigator Caroline Baumal, MD
Min Age 18 Years
Gender All
Contact Michael Dixon
617-636-1051
More Information https://www.clinicaltrials.gov/ct2/show/NCT03622593

Overview

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).

Study Details

Inclusion Criteria

  • 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
  • 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 

Exclusion Criteria

  • 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 

Study Requirements

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.