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临床试验/EUCTR2011-004463-69-DE
EUCTR2011-004463-69-DE进行中(未招募)1 期

Investigation of Radiation Retinopathy (RadiRet Study)Subtitle: Influence of Lucentis® on radiation retinopathy after irradiation of choroidal melanoma - RadiRet Study

Charité – University Medicine Berlin0 个研究点目标入组 60 人开始时间: 2012年8月3日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
60

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

  • Clinical signs of radiation retinopathy (cotton wool spots, hemorrhages, vascular ischemia)
  • Visual impairment due to focal or diffuse radiation induced ME in the irradiated eye that is eligible for laser treatment
  • Age =18 years
  • BCVA less than 20/32
  • 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 30
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 30

排除标准

  • Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent VA improvement, e.g. tumor recurrence, tumor growth underneath the macula
  • Endoresection and / or previous vitrectomy
  • Patients with proliferative retinopathies or macular edema due to reasons other than irradiation: e.g. diabetic retinopathy, vein occlusion, or Irvine-Gass syndrome
  • Treatment with anti-angiogenic drugs or intravitreal corticosteroids or any other investigational drug within 3 months prior to randomisation
  • Prior laser photocoagulation treatment within 3 months (focal / grid laser) or 6 months (panretinal) prior to study entry

研究者

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