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
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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