NCT00417716撤回3 期
The Efficacy of a Single Intravitreal Injection of Bevacizumab in Patients With Diffuse Diabetic Macular Edema
Asociación para Evitar la Ceguera en México1 个研究点 分布在 1 个国家开始时间: 2005年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- BCVA
研究概览
简要总结
Intravitreal Bevacizumab is an effective treatment for the diffuse diabetic macular edema
详细描述
A non-randomized prospective clinical interventional study which includes 45 non previously treated patients with DME. The patients received a single intravitreal injection of 2.5 mg bevacizumab. Follow-up included clinical examination (best corrected visual acuity (BCVA, intraocular pressure (IOP), cataract grading, DME characteristics and systemic check-up) pre-injection, at first visit, at weeks 1 and 2 and months 1 and 3. OCT and fluorescein angiography was evaluated at months 1 and 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Macular edema involving the center of the macula demonstrated on OCT
- •Clear ocular media
- •Untreated patients
- •Older than 45 years
- •BCVA of the fellow eye at least 20/100
排除标准
- •Renal diabetic disease, uncontrolled hypertension or stroke history
- •Other ocular disease
- •Ocular surgery excepting uncomplicated phacoemulsification
- •History of photocoagulation (panretinal or focal)
- •History of another intravitreal treatment (like triamcinolone)
结局指标
主要结局
BCVA
Fluorescein Angiography
Optical Coherence Tomography
次要结局
未报告次要终点
研究者
研究点 (1)
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