临床试验/NCT00344617

NCT00344617Unknown3 期

Off-Label Use of AVASTIN (BEVACIZUMAB)Intravitreal Injection For the Treatment of Serosanguinous Maculopathy

Singapore National Eye Centre0 个研究点目标入组 50 人开始时间: 2006年6月最近更新: 2007年9月26日

适应症

试验速览

阶段: 3 期
发起方: Singapore National Eye Centre
入组人数: 50
主要终点: Change from baseline in VA, i.e. gain or loss of 5 letters (1 line), 15 letters (3 lines) or 30 letters (6 lines)

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

To assess the use of Avastin for the management of serosanguinous maculopathy

详细描述

METHODOLOGY

Patients will be recruited from the vitreoretinal clinics at SNEC. After initial assessment, clinically and angiographically, the patient will be counselled with regards to diagnosis, prognosis and management options, including the option of intravitreal Avastin.

Inclusion criteria:

All subfoveal/juxtafoveal CNV and PCV (polypoidal choroidal vasculopathy) who are not eligible for other treatment options (compassionate use)
CNV and PCV lesions which have failed PDT, conventional argon laser photocoagulation (salvage use)
CNV and PCV lesions treatable with PDT, but cannot afford or refused

Exclusion criteria:

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: 50 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•All subfoveal/juxtafoveal CNV and PCV (polypoidal choroidal vasculopathy) who are not eligible for other treatment options (compassionate use)
•CNV and PCV lesions which have failed PDT, conventional argon laser photocoagulation (salvage use)
•CNV and PCV lesions treatable with PDT, but cannot afford or refused

排除标准

•Patients with uncontrolled hypertension (systolic BP greater than 150mmHg or diastolic BP greater than 90mmHg
•History of thrombolic events such as myocardial infarction or cerebral vascular accident
•Renal abnormalities (as defined by established history of chronic renal disease or renal failure as well as patients requiring dialysis).
•Recent (as defined as the past 28 days) or planned (as defined as the next 3 months) surgery.
•Coagulation abnormalities, including anti-coagulant medication other than aspirin
•Patients with peptic ulcer disease
•Pregnant or lactating females

结局指标

主要结局

Change from baseline in VA, i.e. gain or loss of 5 letters (1 line), 15 letters (3 lines) or 30 letters (6 lines)

次要结局

Change in OCT measured central retinal thickness
Correlation in change in central retinal thickness and change in VA

研究者

发起方

Singapore National Eye Centre

申办方类型

Other Gov

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