EUCTR2010-024062-22-GB进行中（未招募）1 期
A prospective, randomised controlled trial of Ranibizumab pre-treatment in Diabetic Vitrectomy – a pilot study. - A pilot RCT of ranibizumab in diabetic vitrectomy - The RaDiVit Study
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
- •1.Patients of either sex aged 18 years or over
- •2.Diagnosis of diabetes mellitus (type 1 or type 2). Any one of the following will be considered to be sufficient evidence that diabetes is present:
- •a)Current regular use of insulin for the treatment of diabetes
- •b)Current regular use of oral anti-hyperglycaemic agents for the treatment of diabetes
- •c)Documented diabetes by ADA and/or WHO criteria (see Procedures Manual for Diagnosis of Diabetes)
- •3.Proliferative diabetic retinopathy with complications of this requiring vitrectomy surgery with anticipated delamination of pre-retinal fibrovascular complexes
- •4.Ability to return for study visits
- •5.Ability to give informed consent throughout the duration of the study
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Hypersensitivity to the active substance or to any of the excipients.
- •2.Active or suspected ocular or periocular infections.
- •3.Vitreous haemorrhage presumed to be caused by vitreous traction on a single, focal point of vitreoretinal attachment
- •4.Cataract that, in the opinion of the investigators, would be significant enough to impair the view during surgery
- •5. Active severe intraocular inflammation
- •6.Previous vitrectomy surgery on study eye
- •7.Vision in fellow eye 3/60 or worse
- •8.Uncontrolled glaucoma
- •9.History of cerebrovascular accident, peripheral vascular disease, angina or myocardial infarction within six months prior to randomisation
- •10.Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomisation
- •11.Pregnancy or lactation
- •12. Unwillingness to use contraception for the duration of the study
研究者
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