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临床试验/NCT00369863
NCT00369863已完成2 期

A Randomized, Placebo-Controlled Clinical Trial of Intravitreal Triamcinolone for Refractory Diabetic Macular Edema

Shahid Beheshti University of Medical Sciences2 个研究点 分布在 2 个国家目标入组 76 人开始时间: 2002年6月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
76
试验地点
2
主要终点
Central macular thickness

研究概览

简要总结

To determine the efficacy and safety of intravitreal triamcinolone acetonide for refractory diabetic macular edema.

详细描述

Overall 80% of diabetic patients with low vision are in the nonproliferative stage and the main cause of decreased visual acuity is macular edema.

According to the early treatment diabetic retinopathy study (ETDRS), the treatment of choice for diabetic macular edema (DME) is laser therapy, which may be neither effective nor curative in some patients.There are many cases which are refractory to laser treatment or not suitable candidates for it.

Corticosteroids might have a beneficial effect on DME. They have been used with different doses and routes (periocular,intravitreal,and slow released implants) for a variety of retinal diseases.

Recently, a few prospective randomized studies, concerning the effect of intravitreal triamcinolone acetonide (IVT) on DME have been published. In their two-year results, Gillies et al. concluded that IVT improved vision and reduced macular thickness in eyes with refractory diabetic macular edema. They showed that this beneficial effect persisted for up to 2 years with repeated treatment.

We also conducted a randomized placebo-controlled clinical trial to determine the safety and efficacy of IVT for intractable DME. Besides, we tried to evaluate the effect of this intervention on angiographic findings of these patients.

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
Single

入排标准

年龄范围
44 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinically significant macular edema(CSME)
  • Clinically significant macular edema(CSME)refractory to initial or supplemental macular photocoagulation

排除标准

  • Mono-ocular patients
  • History of vitrectomy
  • Glaucoma or ocular hypertension
  • Significant media opacity
  • Traction on the macula

结局指标

主要结局

Central macular thickness

次要结局

  • Visual acuity
  • intraocular pressure
  • Cataract progression
  • Cystoid macular edema
  • Macular hard exudates
  • Macular leakage severity in FA

研究者

研究点 (2)

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