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临床试验/NCT01614509
NCT01614509已完成不适用

Combined Therapy of Posterior Subtenon Triamcinolone Acetonide and Intravitreal Bevacizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion

Yeungnam University College of Medicine2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
2
主要终点
Changes of Central Retinal Thickness

研究概览

简要总结

This study compares the efficacy of intravitreal bevacizumab monotherapy only or combined therapy of posterior subtenon's triamcinolone acetonide and intravitreal bevacizumab for the treatment of macular edema associated with branch retinal vein occlusion.

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
None

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The participant must have macular edema associated branch retinal vein occlusion.
  • The participant has retinal photographs, optical coherence tomography (OCT) and angiography of sufficient quality, allowing assessment of the macular area according to standard clinical practice.
  • The participant must be willing and able to comply with the protocol.

排除标准

  • The participant has BRVO with other ocular vascular diseases such as central retinal vein occlusion, hypertensive retinopathy, etc.
  • The participant has any additional ocular diseases that have irreversibly compromised or could likely compromise the visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema, severe non proliferative diabetic retinopathy, or proliferative diabetic retinopathy.
  • The participant has a history of treatment for BRVO in the study eye with focal laser photocoagulation, intravitreal triamcinolone acetonide injection or intravitreal Bevacizumab injection
  • The participant has a history of intraocular surgery (including lens replacement surgery).
  • The participant has a history of ocular trauma, or current ocular or periocular infection (including any history of ocular herpes zoster or simplex).

结局指标

主要结局

Changes of Central Retinal Thickness

时间窗: baseline, 1, 3, 6 months after injection

Changes of central retinal thickness on optical coherence tomography (OCT) at baseline and 1, 3, 6 month after injection

次要结局

  • Additional Intravitreal Bevacizumab Injection(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Min Sagong

Assistant Professor

Yeungnam University College of Medicine

研究点 (2)

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