NCT00131144已完成3 期
A Randomized, Controlled Study on the Efficacy and Safety of Octreotide Acetate in Microspheres in the Therapy of Patients With Moderately Severe or Severe Non-proliferate Diabetic Retinopathy (NPDR) or Low Risk Proliferative Diabetic Retinopathy (PDR)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 583
- 试验地点
- 1
- 主要终点
- time to progression of diabetic retinopathy
研究概览
简要总结
The most common ocular disease in patients with diabetes, diabetic retinopathy, is present in approximately 40% of diabetic patients; about 8% of diabetic patients have vision threatening diabetic retinopathy. Although intensive control of blood glucose has been shown to reduce the development and progression of diabetic retinopathy, intensive control of glucose is usually not achieved in clinical practice.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females with type 1 and type 2 diabetes mellitus
- •Moderately severe or severe NPDR or mild PDR in at least one eye:
- •with an Early Treatment Diabetic Retinopathy Study (ETDRS) visual score of > 35 letters; and
- •not previously treated with scatter photocoagulation.
- •HbA1c < 13% at study entry
排除标准
- •Condition which could interfere with the assessment of retinopathy progression
- •History of symptomatic gallstones without cholecystectomy
- •Brittle diabetes or history of severe hypoglycemia unawareness
- •Previous treatment with a somatostatin analogue
研究组 & 干预措施
Octreotide Acetate in Microspheres 20 mg
Experimental
20 mg will be administered im once every 4 weeks
干预措施: Octreotide Acetate in Microspheres 20 mg (Drug)
Octreotide Acetate in Microspheres 30 mg
Experimental
30 mg will be administered im once every 4 weeks
干预措施: Octreotide Acetate in Microspheres (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
time to progression of diabetic retinopathy
时间窗: throughout study
次要结局
- time to development or progression of macular edema, and(Baseline through end of study)
- time to moderate vision loss(Baseline through end of study)
研究者
研究点 (1)
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