JPRN-jRCT2080224090已完成3 期
A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of RO6867461 in Patients With Diabetic Macular Edema (YOSEMITE)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 940
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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
排除标准
- •- 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
研究者
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