NCT00440609已完成1 期
A Phase I/II Study Comparing the Treatment of Clinically Significant Diabetic Macular Edema (CSDME) With 0.5mg Ranibizumab, 1.0mg Ranibizumab and 2.0mg Ranibizumab
Philip J. ferrone, M.D.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2007年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To evaluate safety and tolerability of ranibizumab in patients with clinically significant diabetic macular edema
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of Ranibizumab in patients with Clinically Significant Diabetic Macular Edema (CSDME). It will also compare treatment outcomes for patients receiving 0.5mg Ranibizumab and higher doses of 1.0mg and 2.0mg Ranibizumab.
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 (Participant)
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
- •Type I or Type II diabetic subjects
- •Vision between 20/20 and 20/400
- •Presence of Clinically Significant Diabetic Macular Edema
排除标准
- •Presence of any condition that would prevent clear visualization of the back of the eye
- •Uncontrolled glaucoma
- •Complications of glaucoma
- •Inflammation inside the eye
- •Certain prior eye surgeries, other than cataract surgery
- •Other eye diseases that may compromise the vision in the study eye
- •Certain prior eye treatments
- •Pregnancy
- •Uncontrolled health conditions
- •History of heart attack
- •History of stroke
- •Current participation in another investigational trial
研究组 & 干预措施
0.5mg transitioning to 2.0mg
Active Comparator
Ranibizumab-intravitreal injection
干预措施: ranibizumab (Drug)
1.0 mg transitioning to 2.0mg
Active Comparator
Ranibizumab-intravitreal injection
干预措施: ranibizumab (Drug)
结局指标
主要结局
To evaluate safety and tolerability of ranibizumab in patients with clinically significant diabetic macular edema
时间窗: month 12
To compare the treatment of clinically significant diabetic macular edema with 0.5 mg of ranibizumab to 1.0 mg ranibizumab
时间窗: month 12
次要结局
- Mean change in visual acuity as measured by ETDRS from baseline to month 12, 24 36,48 and 60 in each arm.(month 12, 24, 36, 48 and 60)
- Mean change in central retinal thickness on OCT from baseline to month 12, 24, 36, 48 and 60 in each arm(month 12, 24, 36,48 and 60)
- Changes observed on the fluorescein angiogram in each arm(Month 60)
- Mean number of ranibizumab injections required in each arm(Month 60)
- The need for "rescue therapy" with laser in each arm(Month 60)
- Evaluate the efficacy and safety of ranibizumab in the fellow eye in the sub-group of patients who require treatment for clinically significant diabetic macular edema in the fellow eye(Month 60)
研究者
Philip J. ferrone, M.D.
Prinicpal Investigator
Long Island Vitreoretinal Consultants
研究点 (1)
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