NCT01297569已完成4 期
An Open-label, Prospective, Multicentre, Uncontrolled, Proof of Concept Study Assessing the Efficacy of Lucentis (Ranibizumab) Administered by an Individualized "Treat and Extend" Dosing Regimen in Patients With Visual Impairment Due to Diabetic Macular Edema
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change in Best Corrected Visual Acuity(BCVA)
研究概览
简要总结
This study is designed to explore a more individualized treatment regime based on achievement of disease stability to define a personal optimal treatment interval with ranibizumab in patients with visual impairment due to diabetic macular edema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 18 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Visual impairment due to focal or diffuse macular edema with center involvement
- •Diabetes type 1 or 2, HbA1c < 12.0%
- •CRT = or > 250 μm
排除标准
- •Active inflammation or infection
- •Uncontrolled glaucoma
- •Iris neovascularization, active proliferative retinopathy or vitreomacular traction
- •Prior laser photocoagulation according to defined timelines
- •History of stroke, uncontrolled hypertension
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Ranibizumab
Experimental
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Change in Best Corrected Visual Acuity(BCVA)
时间窗: from month 0 (baseline) to month 12
次要结局
- change in central retinal thickness (CRT)(from month 0 to month 12)
- the number of injections needed(12 months)
- the number of patients with improvement in BCVA from baseline(12 months)
- the number of patients with > 5, 10 and 15 letters improvement from baseline, the latter including patients reaching BCVA >84(12 months)
研究者
研究点 (1)
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