EUCTR2012-003943-32-DE进行中（未招募）1 期
Influence of diabetes control on treatment of diabetic macular edema with ranibizumab
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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 diabetic macular edema relevant to visual acuity
- •-OCT retinal thickness >= 250µm
- •-HbA1c > 6,5% at initial visit
- •-BCVA <= 0.8 and >= 0,05
- •-Age >= 18 years
- •-Written informed consent given
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •-Previous treatment with intravitreal drugs in last 6 months
- •-Vitreous hemorrhage as a consequence of proliferative retinopathy which would hamper adequate diagnosis and imaging
- •-Blood pressure of >= 180/100 (or uncontrolled pressures under pharmacological therapy)
- •-Chronic systemic or ocular inflammatory/autoimmune diseases (e.g. inflammatory bowel disease, Addison´s disease, Cushing Syndrome, Uveitis)
- •-Systemic cortisone or anti-VEGF therapy
- •-Acute systemic or ocular infectious diseases
- •-Prior laser photocoagulation treatment within 3 months (focal / grid laser or panretinal) prior to study entry
- •-Current treatment with pharmaceutical preparations with which interactions can be expected
- •-Persons who have a fluorescein allergy
- •-Women who are pregnant or breast feeding
研究者
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