DRKS00005443进行中（未招募）4 期
Ranibizumab and Vitrectomy in the Therapy of Diabetic Macular Edema - RAVIT-DME
Augenklinik Universitätsallee0 个研究点目标入组 15 人开始时间: 2013年11月12日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Patients aged 18 years and older
- •- - - Diabetes mellitus type 2 (insulin-dependent diabetes mellitus (IDDM) and noninsulin-dependent diabetes mellitus (NIDDM))
- •- - - Clinical significant diabetic macular edema (diffuse or focal)
- •- - - Visual acuity (decimal) reduced by diabetic macular edema to = 0,3 and = 0,05 (LogMar = 1,3 and = 0,5) stated by EDTRS charts.
- •- - - Signed informed consent
排除标准
- •The investigator is clinically not convinced about vitrectomy being indicated or the possible side effects outweigh the possible positive effects of vitrectomy
- •- - - Diabetes mellitus type 1
- •- - - Visual acuity of the study eye (decimal) > 0,3 (LogMar < 0,5)
- •- - - Visual acuity of the study eye (decimal) < 0,05 (LogMar > 1,3)
- •- - - Central retinal thickness stated by SD-OCT < 250 µm
- •- - - Any clouding of optical media influencing the evaluation of the retina
- •- - - Previous focal laser coagulation of the macula in the study eye within 3 months prior to baseline
- •- - - Previous treatment of diabetic macular edema involving intravitreal steroids or VEGF blockers within 3 months prior to baseline
- •- - - Previous vitrectomy in the study eye
- •- - - Previous cataract surgery in the study eye within 3 months prior to baseline
- •- - - Pseudophakia with opening of the posterior capsule by surgery or YAG laser capsulotomy within 3 months prior to baseline
- •- - - History of glaucoma (including or excluding local or systemic therapy) in either eye
- •- - - Uveitis or extraocular inflammation in either eye
- •- - - Pseudoexfoliative syndrome
- •- - - Known ocular ischemia syndrome in either eye (occlusion of extraocular arteries, influencing the vascularisation of the study eye)
- •- - - Retinal venous occlusion in the study eye
- •- - - History of retinal detachment (including or excluding any therapy) in either eye
- •- - - Tractive retinal detachment due to diabetic epiretinal proliferation in the study eye
- •- - - Intravitreal hemorrhage interfering with the assessment of the posterior pole in the study eye prior to baseline
- •- - - Active malignancies (history of successful treated malignancies is not an exclusion criterion)
- •- - - History of cerebral vascular accident or myocardial infarction within 12 months prior to baseline
- •- - - Diabetes mellitus with HbA1c > 10 % or if it can be expected that the patient’s diabetes cannot be controlled adequately during the trial
- •- - - Uncontrolled arterial Hypertension defined as a systolic value of > 180 mmHg and/or a diastolic value of > 110 mmHg
- •- - - Systemic therapy with steroids or anticoagulative therapy with coumarin derivatives or heparin (Aspirin or Clopidogrel is allowed)
- •- - - History of allergy to fluorescein or ranibizumab
- •- - - Women who are pregnant or planning a pregnancy
- •- - - Women who are breast feeding
- •- - - Inability to comply with study or follow-up procedures
研究者
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