NCT00737971已完成4 期
A Randomized, Parallel Group, Masked Clinical Study to Evaluate the Efficacy of Triamcinolone and Bevacizumab Through Intravitreal Injection With Individual or Simultaneous Drugs to Treatment of Diabetic Macular Edema
Rubens Belfort Jr.1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2008年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Measurement of visual acuity (E Snellen)
研究概览
简要总结
Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema
详细描述
Efficacy Study of Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema
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
- Double (Participant, Investigator)
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
- •18 years of age at least
- •Diagnosis of diabetes mellitus (type 1 or type
- •any one of the following will be considered to be sufficient evidence that diabetes is present:
- •current regular use of insulin for the treatment of diabetes
- •current regular use of oral hypoglycemic agents for the treatment of diabetes
- •diabetes as defined by american Diabetes Association (ADA)
- •symptoms of diabetes (polyuria, polydipsia, and unexplained weight loss) or eighth-hour fasting plasma glucose > 126 mg/dl
- •Diabetic macular edema clinically observable associated with diabetic retinopathy:
- •without prior foveal treatment with laser therapy
- •if photocoagulation or peripherical or macular laser, at least 3 months
- •absence of macular ischemia by fluorescein angiography on baseline visit
- •BCVA score between 20 letters (20/400 ETDRS)e 70 letters (20/40 ETDRS) in the study eye measured by the ETDRS method at qualification/baseline visit
- •Retinal thickness > 275um by OCT
- •One eye per patient will be chosen for the study. In case of both eye eligible, it will be chosen an eye to be treated with study medication and another eye treated with laser
- •Taught hyaloid syndrome
排除标准
- •Uncontrolled systemic disease
- •Initiation of medical therapy for diabetes or a change from oral hypoglycemic agents to insulin therapy within 4 months prior to the qualification visit
- •Renal failure requiring hemodialysis or peritoneal dialysis within 6 months prior to the qualification visit
- •Any ocular condition in the study eye that in the opinion of the investigator would prevent a 2 lines improvement of visual acuity (e.g. severe macular ischemia)
- •Presence of branch retinal vein occlusion, central retinal vein occlusion, uveitis, pseudophakic cystoid edema or any other condition in the study eye which could be contributing to macular edema
- •Presence of an epiretinal membrane in the study eye
- •History of IOP elevation in response to steroid treatment in either eye
- •History of glaucoma or optic nerve head change consistent with glaucoma damage
- •Ocular hypertension requiring more than 1 anti-glaucoma medication to maintain IOP < 11mmhg at qualification visit
- •Presence of anterior chamber intraocular lens in the study eye
- •Active optic disc or retinal neovascularization in the study eye at qualification visit
- •Active or history of choroidal neovascularization in the study eye
研究组 & 干预措施
A
Active Comparator
Avastin intravitreal injection D0, Week 4, Week 8
干预措施: Bevacizumab intravitreal (Drug)
B
Active Comparator
Triamcinolone intravitreal injection
干预措施: Triamcinolone (Drug)
C
Active Comparator
Avastin + Triamcinolone intravitreal injection simultaneously
干预措施: Triamcinolone + Bevacizumab (Drug)
结局指标
主要结局
Measurement of visual acuity (E Snellen)
时间窗: monthly
次要结局
- Tonometry(monthly)
- Measurement of retinal thickness by OCT(monthly)
研究者
Rubens Belfort Jr.
Head Professor
Federal University of São Paulo
研究点 (1)
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