EUCTR2013-001856-36-FR进行中（未招募）不适用
Efficacy and safety of Aflibercept (Eylea®) in proliferative diabetic retinopathy - MEDICARE
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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 patients with proliferative diabetic retinopathy
- •- Aged 18 years old or more
- •- Best corrected visual acuity score = 35 letters
- •- Glycosylated hemoglobin rate < 11% at inclusion
- •- Systolic blood pressure < 160 mmHg and diastolic blood pressure < 105 mmHg at inclusion
- •- Clear ocular media allowing fundus examination
- •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 10
排除标准
- •- Any history of retinal laser photocoagulation
- •- Any history of intravitreal injection
- •- Any history of vitrectomy
- •- proliferative diabetic retinopathy associated to retinal detachment
- •- proliferative diabetic retinopathy associated to fibrovascular proliferation
- •- florid proliferative diabetic retinopathy
- •- Allergy to fluorescein
- •- Active infectious disease
- •- Any significant recent (less than 3 months) cardiovascular disorder (angina pectoris, myocardial infarction, renal failure)
- •- Any ocular disorder that could prevent retinal examination (cataract)
- •- Significant macular edema =350 µm.
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