EUCTR2012-001006-24-DE进行中（未招募）1 期
Ranibizumab and Vitrectomy in the Therapy of Diabetic Macular Edema (The RAVIT-DME-Trial) - RAVIT-DME
未提供0 个研究点目标入组 110 人开始时间: 2013年6月24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）
- 入组人数
- 110
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 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.
- •?The investigator has to be clinically convinced about vitrectomy might be beneficial and appropriate for the patient enrolled.
- •?Signed informed consent
- •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 110
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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 6 months prior to baseline
- •?Previous vitrectomy in the study eye
- •?Previous cataract surgery in the study eye within 6 months prior to baseline
- •?Pseudophakia with opening of the posterior capsule by surgery or YAG laser capsulotomy 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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