A Canadian 12-month, Prospective, Randomized, Open-label, Multicenter, Laser-controlled Phase IIIb Study Assessing the Efficacy, Safety and Cost-efficacy of Ranibizumab as Combination and Monotherapy in Patients With Visual Impairment Due to Diabetic Macular Edema.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 241
- 试验地点
- 20
- 主要终点
- Mean Change From Baseline in Best Corrected Visual Acuity- (BCVA) at Month 12
研究概览
简要总结
To evaluate, specifically within the Canadian medical environment, the efficacy, safety and cost-efficacy of ranibizumab administered either as combination therapy (ranibizumab plus laser photocoagulation), or as monotherapy in comparison with the current standard of care (laser photocoagulation monotherapy), in patients with visual impairment due to DME.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable Type 1 or Type 2 diabetes mellitus
- •Visual impairment due to focal or diffuse DME in at least one eye
排除标准
- •Active conditions in the study eye that could prevent the improvement of visual acuity on study treatment
- •Active eye infection or inflammation
- •History of stroke, renal failure or uncontrolled hypertension
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Combination Therapy
Participants received ranibizumab intravitreal injection and laser photocoagulation treatments
干预措施: ranibizumab (Drug)
Combination Therapy
Participants received ranibizumab intravitreal injection and laser photocoagulation treatments
干预措施: Laser (Procedure)
Ranibizumab Monotherapy
Participants received ranibizumab intravitreal injection therapy only
干预措施: ranibizumab (Drug)
Laser Monotherapy
Participants received Laser photocoagulation therapy only
干预措施: Laser (Procedure)
结局指标
主要结局
Mean Change From Baseline in Best Corrected Visual Acuity- (BCVA) at Month 12
时间窗: Baseline and 12 months
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of BCVA (EDTRS) is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement.
次要结局
- Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Months 3,6 and 9(Baseline, 3, 6 and 9 months)
- Percentage of Patients Achieving a Gain of 15-letters or More (3-lines) in BCVA From Baseline(Baseline, 3, 6, 9 and 12 months)
- Time Trade-Off Questionnaire - 25 (TTO) Composite Score at Month 12(12 month)
- Change From Baseline in Central Retinal Thickness (CRT) at Months 3,6,9 and 12(Baseline, 3, 6, 9 and 12 months)
- Percentage of Patients Achieving Gain of Letters From Baseline in BCVA(12 months)
- National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) Composite Score at Month 12(12 month)
- EuroQoL (EQ-5D) Utility Score at Month 12(12 month)