A 12-month, Randomized, Double-masked, Multicenter, Laser-controlled Phase III Study Assessing the Efficacy and Safety of 0.5 mg Ranibizumab Dosed PRN in Subjects With Visual Impairment Due to Diabetic Macular Edema in Chinese Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Mean Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) (Letters) to Month 1 Through 12
研究概览
简要总结
Study of efficacy and safety of 0.5 mg ranibizumab in Chinese patients with diabetic macular edema (DME)
详细描述
The purpose of this study was to provide efficacy and safety data on 0.5 mg ranibizumab intravitreal injections compared to laser photocoagulation in Chinese patients with visual impairment due to DME. Treatment was driven by achieving vision stabilization.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female Chinese patients ≥ 18 years of age with diabetes mellitus and with HbA1c ≤10.0%
- •Stable medication for diabetes within 3 months prior to Visit 1
- •Visual impairment due to DME with BCVA score between 78 and 39 letters as measured by ETDRS-like charts at 4 meters
排除标准
- •Stroke or myocardial infarction less than 3 months prior to screening visit
- •Uncontrolled hypertension
- •Active ocular infection or intraocular inflammation in any eye
- •Treatment with any anti-angiogenic drugs within 3 months prior to baseline visit in any eye
- •Active proliferative diabetic retinopathy in study eye
- •Use of other investigational drugs within 30 days and systemic anti-VEGF drugs within 6 months prior to baseline visit
- •Prior laser photocoagulation or intraocular procedure within 3 months prior to baseline in study eye
- •History of intravitreal corticosteroid treatment in phakic study eye, and in aphakic or pseudophakic within 3 months prior to screening
研究组 & 干预措施
Ranibizumab (RFB002)
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
干预措施: Ranibizumab (RFB002) (Drug)
Ranibizumab (RFB002)
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
干预措施: Sham laser (Procedure)
Laser
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
干预措施: Laser (Procedure)
Laser
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
干预措施: Sham injection (Drug)
结局指标
主要结局
Mean Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) (Letters) to Month 1 Through 12
时间窗: Baseline, Monthly from Month 1 through Month 12
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. Twelve monthly BCVA values were averaged \[(Month1+Month2+...+Month12)/12\], and the baseline BCVA value was subtracted from the average. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
次要结局
- Mean Change From Baseline in BCVA (Letters) at Each Visit(Baseline, Monthly from Month 1 through Month 12)
- Percentage of Patients With BCVA Gain of ≥ 10 and ≥ 15 Letters From Baseline at Month 12(Baseline, Month 12)
- Percentage of Patients With BCVA Loss of < 10 and < 15 Letters From Baseline to Month 12(Baseline, Month 12)
- Mean Change From Baseline in Patient-Reported General Health at Month 6 and Month 12(Baseline, Month 6, Month 12)
- Mean Change From Baseline in Central Sub-Field Thickness (CSFT) at Each Visit(Baseline, Monthly from Month 1 through Month 12)
- Mean Average Change in BCVA From Month 4 to Month 12 Compared to Month 3(Monthly from Month 3 through Month 12)
- Mean Change From Baseline in Patient-Reported Social Functioning at Month 6 and Month 12(Baseline, Month 6, Month 12)
- Mean Change From Baseline in Patient-Reported Visual Functioning at Month 6 and Month 12, Composite Score(Baseline, Month 6, Month 12)
- Mean Change From Baseline in Patient-Reported Peripheral Vision at Month 6 and Month 12(Baseline, Month 6, Month 12)
- Mean Change From Baseline in Patient-Reported Ocular Pain at Month 6 and Month 12(Baseline, Month 6, Month 12)
- Mean Change From Baseline in Patient-Reported Roles Difficulties at Month 6 and Month 12(Baseline, Month 6, Month 12)
- Percentage of Patients With BCVA ≥ 73 Letters at Month 12(Month 12)
- Mean Change From Baseline in Patient-Reported Mental Health at Month 6 and Month 12(Baseline, Month 6, Month 12)
- Mean Change From Baseline in Patient-Reported Driving at Month 6 and Month 12(Baseline, Month 6, Month 12)
- Mean Change From Baseline in Patient-Reported General Vision at Month 6 and Month 12(Baseline, Month 6, Month 12)
- Mean Change From Baseline in Patient-Reported Color Vision at Month 6 and Month 12(Baseline, Month 6, Month 12)
- Mean Change From Baseline in Patient-Reported Distance Activities at Month 6 and Month 12(Baseline, Month 6, Month 12)
- Mean Change From Baseline in Patient-Reported Dependency at Month 6 and Month 12(Baseline, Month 6, Month 12)
- Mean Number of Ranibizumab Re-treatments Received in the Study Eye From Month 3 Onward(Monthly from Month 3 through Month 12)
- Mean Change From Baseline in Patient-Reported Near Activities at Month 6 and Month 12(Baseline, Month 6, Month 12)