NCT00248131终止3 期
An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Octreotide Acetate in Microspheres in the Therapy of Patients With Moderately Severe or Severe Non-proliferative Diabetic Retinopathy (NPDR) or Low Risk Proliferative Diabetic Retinopathy (PDR)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 260
- 主要终点
- long-term safety and tolerability
研究概览
简要总结
This multicenter, open-label extension study will evaluate the long-term tolerability and safety for patients completing study CSMS995 0802. During this extension study, all patients will receive open-label treatment of octreotide acetate in microspheres every 4 weeks for 2 years for the treatment of moderately severe to severe NPDR and low risk PDR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent provided prior to participation in the extension study
- •successful completion of study CSMS995 0802
- •willingness to comply with all study requirements
排除标准
- •more than 8 weeks interval since the completion of study CSMS995 0802
- •premature discontinuation from study CSMS995 0802
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
long-term safety and tolerability
次要结局
- monitor long-term efficacy
研究者
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