Clinical Trials // Diabetic Macular Edema // Jonathan Chang // Ongoing // Jan 28 2019
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
To evaluate the efficacy, safety, and pharmacokinetics of faricimab compared with aflibercept, in participants with diabetic macular edema.
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.
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
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