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临床试验/NCT02033031
NCT02033031已完成3 期

Treatment With Anti-vascular Endothelial Growth Factor in Patients With Branch Retinal Vein Occlusion: 5 Years of Clinical Experience

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2012年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
28
试验地点
1
主要终点
visual acuity

研究概览

简要总结

Retinal vein occlusion (RVO) is the second leading cause of retinal vascular disease in patients older than 50 years.The prevalence varies from 0.7% to 1.6% in the literature.

Visual recovery depends on ischemic damage of the retina, the occurence of macular edema (ME) and the development of neovascular glaucoma. The occurence of ME is the main reason for visual loss and frustrates visual recovery among patients with both central or branch RVO.

Therapeutic options that have been used and discussed over the years are the treatment with anticoagulants, fibrinolytics, corticosteroids, acetazolamide and isovolemic haemodilution. Furthermore, surgical options like vitrectomy and radial optic neurotomy were used. Panretinal photocoagulation and grid pattern photocoagulation had established as additional tool to induce chorioretinal anastomosis. Nevertheless, the effectiveness and the evidence of these different treatment options could not be verified and remains mostly unknown.

Nowadays, intravitreal anti-VEGF application had become the treatment of choice for ME secondary to RVO. Multi-center studies have already shown the effectiveness of anti-VEGF treatment to reduce intraretinal fluid and retinal hemorrhages (BRAVO, CRUISE). Unfortunately, often high numbers of re-treatments become necessary over the years. In our knowledge, there are no reports showing more than 3 years treatment effects of antiangiogenic drugs in patients with BRVO. However, the results of treatment effect longer than 3 years are important, as the mean age < 70 years with an onset of BRVO has been estimated in about 60% of all cases. In addition, most patients with regard to the application of anti-VEGF treatment in real clinical setting, there is only rare experience concerning need of optimum time duration for follow-up at the departments. Hence, the present study aimed to evaluate the long-term clinical outcomes, safety and therapeutic benefit of a flexible dosing regimen of intravitreal anti-VEGF therapy in patients with ME secondary to BRVO.

详细描述

This cross-sectional study evaluates a series of patients with ME due to RVO who were available for at least 4 years' follow-up examination. The patients received either intravitreal ranibizumab (IVR) or bevacizumab (IVB) in a flexible dosing regimen

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Macular edema secondary to Branch retinal vein occlusion

排除标准

  • Aphakia, Glaucoma

研究组 & 干预措施

Lucentis

Active Comparator

PRN intravitreal injection of Lucentis

干预措施: Lucentis intravitreal injection (Drug)

Avastin

Active Comparator

PRN intravitreal injection of Lucentis

干预措施: Avastin intravitreal injection (Drug)

结局指标

主要结局

visual acuity

时间窗: up to 6 months

measurement of visual acuity outcomes; baseline in comparison to long-term

次要结局

  • retinal sensitivity(up to 6 months)
  • central retinal thickness(up to 6 months)
  • treatment rate(up to 6 months)

研究者

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

Stefan Sacu

Prof. Dr

Medical University of Vienna

研究点 (1)

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