EUCTR2013-000031-27-GB进行中（未招募）1 期
Intravitreal Ranibizumab (Lucentis) Therapy in Patients with Diabetic Ischaemic Macular Oedema (DIME) - The DIME Study - Lucentis in Ischaemic Diabetic Macular Oedema
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
- 80
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
- •Age >= 18 years
- •Diagnosis of diabetes mellitus (type 1 or type 2)
- •Best corrected ETDRS visual acuity letter score at 4 metres (and approximate Snellen equivalent), between 20 and 70 letters (6/12 – 3/60)
- •Centre-involving diabetic macular oedema
- •Central macular thickness (CMT) = 300 µm on Spectralis SD-OCT
- •Enlarged foveal avascular zone (FAZ greatest linear dimension (GLD) =1000 µm) or a non-intact perifoveal capillary ring at the margin of the FAZ with FAZ GLD 700-1000 µm
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Blood pressure > 180/110 (systolic above 180 and diastolic above 110).
- •anti-VEGF treatment to the study eye within 4 months.
- •prior ocular surgery (including vitrectomy, cataract extraction) within 4 months.
- •history of treatment for DME at any time in the past 4 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment).
- •history of panretinal photocoagulation (PRP) within 4 months or anticipated need for PRP in the 6 months following randomization.
- •Intraocular pressure >25 mmHg.
- •conditions/circumstances that preclude/significantly reduce the likelihood of response to therapy e.g. macular atrophy or exudative plaque.
研究者
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