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临床试验/DRKS00003246
DRKS00003246进行中(未招募)2 期

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

Charité Campus Benjamin Franklin0 个研究点目标入组 31 人开始时间: 2013年5月31日最近更新:
适应症

试验速览

阶段
2 期
状态
进行中(未招募)
发起方
入组人数
31

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 one(—)
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 macula edema (ME) in the irradiated eye that is eligible for laser treatment
  • Age =18 years
  • BCVA less than 20/32

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
  • Known hypersensitivity against local anaesthetics
  • Known hypersensitivity against iodine

研究者

发起方
Charité Campus Benjamin Franklin

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