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临床试验/NCT00533962
NCT00533962Unknown不适用

Anterior Juxtascleral Depot of Anecortave Acetate: Intraocular Pressure Reduction in Glaucoma Patients

Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2007年8月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Intraocular pressure

研究概览

简要总结

Introduction: Ocular administration of glucocorticoids is a common and effective treatment for several ocular diseases. However it is often complicated with the elevation of intraocular pressure (IOP). Anecortave acetate (AA) is an analog of cortisol acetate and lacks the typical anti-inflammatory and immunosuppressive properties of glucocorticoids. The effect of its anterior juxtascleral depot (AJD) injection has been evaluated in cases of glaucoma caused by intravitreal triamcinolone acetonide, presenting impressive results. The purpose of this study is to evaluate the efficacy and safety of the AA injection as a possible antiglaucoma treatment alternative. Methods: A prospective clinical study will be carried out including 30 glaucoma patients (30 eyes). After inclusion each patient will receive a single AJD injection of 30 mg of AA in the selected eye. Main outcome measure include: intraocular pressure at 1st day, 7th day, 1st, 2nd and 3rd months.

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
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Advanced glaucoma cases with surgery or cyclophotocoagulation indication (IOP over 25 mmHg)
  • Patients should be under maximum tolerated medication
  • Low best corrected visual acuity (worse than 20/100)

排除标准

  • Under 18 or over 80

结局指标

主要结局

Intraocular pressure

时间窗: Procedure

次要结局

  • Visual Acuity; side effects (biomicroscopy exam)(Post treatment)

研究者

发起方
Federal University of São Paulo
申办方类型
Other

研究点 (2)

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