A 12-months, Randomized, VA-assessor Blinded, Multicenter, Controlled Phase IV Trial to Investigate Noninferiority of Two Treatment Algorithms (Discretion of the Investigator vs. Pro re Nata) of 0.5 mg Ranibizumab in Patients With Visual Impairment Due to Diabetic Macula Edema
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Mean Average Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye From Month 1 to Study Treatment Completion (Month 12)
研究概览
简要总结
The purpose of this study was to demonstrate that the change of best corrected visual acuity (BCVA) was comparable in patients treated with ranibizumab at the discretion of the investigator vs. treatment according to a standard of care scheme (pro re nata, as needed).
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
- Single (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
- •Patients with Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) ≤ 12.0%
- •Patients with visual impairment due to DME in at least one eye
- •BCVA ≥ 24 and ≤ 78 letters in the study eye
排除标准
- •Active intraocular inflammation
- •Any active infection in either eye at the
- •Structural damage within 0.5 disc diameter of the center of the macula in the study eye
- •Uncontrolled glaucoma in either eye at screening
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Discretion of the investigator (DI)
ranibizumab 0.5 mg, after initial monthly treatment until maximum BCVA and no signs or no further change of disease activity, the investigator treated patients at their own discretion. There were no strict recommendations for retreatment or scheduling of upcoming visits.
干预措施: ranibizumab 0.5 mg (Drug)
Pro re nata (PRN)
ranibizumab 0.5 mg, after initial monthly therapy until maximum BCVA and no signs or no further improvement of disease activity, patients were monitored every month and retreated if any signs of disease activity occurred
干预措施: ranibizumab 0.5 mg (Drug)
结局指标
主要结局
Mean Average Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye From Month 1 to Study Treatment Completion (Month 12)
时间窗: Baseline, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
BCVA was assessed as letters read using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. The mean average change from baseline was defined as the difference between the average level of BCVA (ETDRS letters) over all post-baseline assessments from Month 1 to Month 12. A positive change represents an improvement in visual acuity
次要结局
- Mean Change of Foveal Center Point Thickness(Baseline to Month 12)
- Number of Injections(Baseline to Month 12)
- Mean Change in Central Subfield Retinal Thickness (CSRT)(Baseline to Month 12)
- Number of Treatment Free Intervals(Baseline to Month 12)
- Number of Visits(Baseline to Month 12)
- Number of Participants With Change in Diabetic Retinopathy Study (DRS) Retinopathy Scale(Baseline to Month 12)