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临床试验/EUCTR2011-004613-17-SE
EUCTR2011-004613-17-SE进行中(未招募)不适用

The effect of intravitreal injections of Lucentis (ranibizumab) on retinal function in diabetic patients with diabetic macular edema and visual impairment

Inst of Ophtalmology Lund University hospital0 个研究点开始时间: 2011年9月20日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Patients with type 1 or 2 diabetes mellitus
  • patients with clinical significant macular edema
  • patients with visual impairment <0.7 (Snellen)
  • Patients with no previous lasertreatment or other treatment for macular edema
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 5
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 15

排除标准

  • 1.Patients with active proliferative retinopathy
  • 2.Duration of macular edema> two years
  • 3.Cataract which causes impaired VA
  • 4.HbA1c > 10 at baseline
  • 5.B-glucos > 20 at baseline
  • 6.Pregnant or nursing women
  • 7.Fertile women not using effective contraception
  • 8.Patients with active och suspected infection in our around the eye
  • 9.Patientes with severe intraocular inflammation
  • 10.Patients with uncontrolled intraocular pressure (IOP) <25 mmHg in spite of treatment 11.Intraocular surgery during the last 3 months befor enrollment
  • 12.Previous treatment for retinaldisease such as trombosis or diabeticretinophaty

研究者

发起方
Inst of Ophtalmology Lund University hospital

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