EUCTR2017-000250-19-ES进行中（未招募）1 期
Effect of calcium dobesilate in early stages of diabetic retinopathy - CADODIAME
Fundació Hospital Universitari Vall d'Hebron - Institut de Recersa (VHIR)0 个研究点目标入组 60 人开始时间: 2017年4月7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）
- 发起方
- 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
- •Patients with type 2 diabetes mellitus.
- •Subclinical diabetic macular edema.
- •ETDRS score 20-47.
- •Duration of diabetes = 5 years.
- •Age between 45 and 70 years (both included)
- •HbA1c =7% and =8.5% in the previous 6 months and at screening.
- •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 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Medical record of laser photocoagulation.
- •Presence of any retinal disease other than diabetic retinopathy.
- •Patients with a refractive error of =5 diopters in one of the two eyes.
- •Pupillary dilation or any eye defect that does not allow good quality images of fundus.
- •Medical record of ocular surgery in the 6 months prior to randomization.
- •Advanced chronic kidney disease (= stage 4).
- •known Allergy or intolerance ti IMP
- •Pregnancy or child-bearing age women that don't accept or can't use anticonceptive methodes during all the study
- •Patients that cannot follow the study indications
- •Use of an IMP within the last 30 days prior to screening visit
研究者
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