A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE)
- Conditions
- diabetic macular edema
- Registration Number
- JPRN-jRCT2080224090
- Lead Sponsor
- CHUGAI PHARMACEUTICAL CO., LTD.
- Brief Summary
Faricimab given every 8 weeks and at personalized dosing intervals of up to 16 weeks demonstrated non-inferior visual acuity gains compared to Aflibercept given every 8 weeks. At least 60% of people eligible for extended dosing with Faricimab could be treated every 4 months at 2 years - a 10% point increase since the primary analyses at 1 year - while achieving non-inferior vision gains versus aflibercept given every 2 months. Faricimab continued to be generally well-tolerated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 940
Type 1 or type 2 diabetes mellitus
- Hemoglobin A1c (HbA1c) of less than or equal to <=10%
- Macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea
- Ability and willingness to undertake all scheduled visits and assessments
- Currently untreated diabetes mellitus or previously untreated patients who initiated oral anti-diabetic medication or insulin 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
- Currently pregnant or breastfeeding, or intend to become pregnant during the study
- Any intraocular or periocular corticosteroid treatment within the past 6 months prior to Day 1 to the study eye
- Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye
- Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Average change from baseline in BCVA at 1 year
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>- Change from baseline in BCVA over time<br>- Percentage of Participants With a >=2-Step Diabetic Retinopathy Severity (DRS) Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) at 1 Year<br>- Percentage of Participants Gaining >=15, >=10, >=5 or >=0 Letters in BCVA From Baseline Over Time <br>- Change from baseline in CST over time<br>- Change from baseline in NEI VFQ-25 composite score over time<br>- Percentage of Participants With Ocular Adverse Events<br>- Percentage of Participants With Non-Ocular Adverse Events
Related Research Topics
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