A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients with Diabetic Macular Edema (YOSEMITE)

  • Sponsor: Hoffmann-La Roche
  • Principal Investigator: Jonathan Chang, MD
  • Study Coordinator: Chris Smith

Study objective:

To evaluate the efficacy, safety, and pharmacokinetics of faricimab compared with aflibercept, in participants with diabetic macular edema.

Study design:

Subjects will be randomized in a 1:1:1 ratio to receive faricimab every 4-8 weeks, faricimab at a personalized treatment interval or aflibercept every 4-8 weeks. A sham procedure will be administered to patients in all three treatment arms at applicable visits to maintain masking among treatment arms. Participation in the study will last approximately 2 years.

Inclusion criteria:

  • Hemoglobin A1c (HbA1c) of less than or equal to (≤) 10% within 2 months prior to day 1
  • Macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea
  • Decreased visual acuity attributable primarily to DME
  • RHONE-X is an open-label extension study and subjects must have previous enrollment in and completion of Study GR40349 (NCT03622580) or GR40398 (NCT03622593), without study or study drug discontinuation

Exclusion criteria:

  • Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to day 1
  • Uncontrolled blood pressure, defined as a systolic value greater than (>)180 millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient is at rest
  • Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye
  • Any intraocular or periocular corticosteroid treatment within the past 6 months prior to Day 1 to the study eye
  • Prior administration of IVT faricimab in either eye
  • Active intraocular or periocular infection or active intraocular inflammation in the study eye

Contact Chris Smith with questions: 608-263-7169.

For more information about this study: