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临床试验/NCT00806169
NCT00806169已完成3 期

Intravitreal Combination Therapy Using Triamcinolone and Bevacizumab Improves Vision in Patients With Diabetic Retinopathy

Johann Wolfgang Goethe University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2006年4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
发起方
入组人数
40
试验地点
1
主要终点
Best Corrected Visual Acuity

研究概览

简要总结

The aim of this pilot study was to investigate the effects of an intravitreal combination therapy using triamcinolone and bevacizumab in patients with macular edema due to diabetic retinopathy.

详细描述

This prospective, monocenter pilot case series was conducted between May 2006 and November 2008. Patients were included because of DME and signs of pre- and early proliferation because of diabetic retinopathy.73 eyes of 56 patients were included, all of which had signed an informed consent to perform a pharmacosurgical procedure consisting of a 23 gauge core Pars Plana Vitrectomy (sutureless single stitch sclerotomy, cutter with 300 cuts/minute) with removement of 1.5ml vitreous and substitution with 1ml BSS, 8mg triamcinolone, and 1.25 mg bevacizumab. At baseline and follow-up, the best corrected visual acuity (BCVA; 6 m Snellen), and intraocular pressure (IOP; Goldmann tonometry), and central macular thickness (optical coherence tomography) were determined. In addition, the need for further treatment and adverse events were monitored.

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

入选标准

  • Diagnosis of diabetic retinopathy
  • macular edema more than 200 micron
  • vitreous bleeding because of angiography documented NVEs NVDs, based on the definitions of ETDRS

排除标准

  • Prior intraocular injection within 4 months
  • Core or complete vitrectomy
  • History of glaucoma or ocular hypertension
  • Presence of iris neovascularization
  • Significant media opacity
  • Monocularity and pregnancy

研究组 & 干预措施

1

Experimental

group I (n=17) nonproliferative DR and ischemic maculopathy

干预措施: triamcinolone and bevacizumab (Drug)

2

Experimental

group II (n=38) nonproliferative DR without ischemic maculopathy

干预措施: triamcinolone and bevacizumab (Drug)

3

Experimental

group III (n=18) proliferative DR with or without ischemic maculopathy

干预措施: triamcinolone and bevacizumab (Drug)

结局指标

主要结局

Best Corrected Visual Acuity

时间窗: Day of exam

次要结局

未报告次要终点

研究者

发起方
Johann Wolfgang Goethe University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Koss

PI

Johann Wolfgang Goethe University Hospital

研究点 (1)

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