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临床试验/EUCTR2008-006879-71-ES
EUCTR2008-006879-71-ES进行中(未招募)不适用

Tratamiento del edema de macula diabético clinicamente significativo con Ranibizumab (LUCENTIS) intravitreo. TREATMENT OF DIABETIC CLINICALLY SIGNIFICANT MACULAR EDEMA WITH INTRAVITREOUS RANIBIZUMAB (LUCENTIS)

HOSPITAL SAN PEDRO0 个研究点开始时间: 2009年2月4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

  • Diabetic type 1 and 2 patients.
  • Diabetic macular edema, diffuse, refractory to laser treatment (decrease in visual acuity during the last six months treatment, with central thickness >250 microns.
  • Less than very severe diabetic retinopathy.
  • Visual acuity >20/320 Snellen (24 letters ETDRS).
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Tractional macular edema diagnosed in optical coherence tomography.
  • Cataract that can require surgery in the following one year.
  • Uncontrolled hypertension with medical treatment (>150/95 mm Hg)
  • Bad glycemic control (HbA1C > 10%).
  • Severe nephropathy.
  • Previous hearth attack.
  • Previous brain vascular disease.
  • Pregnancy or intention of it during the following one year (pregnancy test required)
  • Active ocular inflammation
  • Previous vitrectomy in the study eye.
  • Previous anti-glaucoma treatment that can increase macular edema.
  • Use of any drug that can be toxic to the macula.
  • Previous use of anti-angiogenic drug or intravitreous steroid in the study eye.

研究者

发起方
HOSPITAL SAN PEDRO

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