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临床试验/CTRI/2015/06/005945
CTRI/2015/06/005945已完成4 期

A multi-center, open-label, observational study to evaluate the efficacy and safety of intravitreal injections (IVI) of Ranibizumab in patients with visual impairment due to Diabetic Macular Edema (DME) - UNVEIL- DME

ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
已完成
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

入选标准

  • 1.Patients willing to provide signed, written informed consent
  • 2.Patients with macular edema due to Diabetes (confirmed by fundus photography, fluorescein angiography, OCT)
  • 3.Male and female aged 18 and above.
  • 4.Vision Impairment due to DME (PL + to 6/9 on Snellen chart).

排除标准

  • 1. Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity on study treatment.
  • 2. Active intraocular inflammation in either eye.
  • 3. Uncontrolled glaucoma in the study eye.
  • 4. Active proliferative diabetic retinopathy in the study eye.
  • 5. Any contra-indication according to local Summary of Product Characteristics or Prescribing Information (SmPC or PI) of ranibizumab.

研究者

发起方
ovartis Healthcare Pvt Ltd

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