NL-OMON47349已完成3 期
Comparing the effectiveness and costs of bevacizumab to ranibizumab in patients with diabetic macular edema - BRDME
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 126
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Male or female patients > 18 years of age who have signed an Informed Consent.
- •* Patients with Type 1 or Type 2 diabetes mellitus (according to American Diabetes Association or World Health Organization (WHO) guidelines) with glycosylated haemoglobin (HbA1c) less than 12.0% at screening (Visit 1). Patients should be on a dietary, exercise and/or pharmacological program for diabetes. Treatment for diabetes must have been stable for at least 2 months
- •* Patients with visual impairment due to DME (within the EDTRS criteria of clinically significant macular edema) in at least one eye, with a central area thickness >325 micron, who are eligible for anti-VEGF treatment according to the investigator. If both eyes are eligible, the one with the worse visual acuity, as assessed at Visit 1, will be selected by the investigator as the study eye.
- •* BCVA equal or more than 24 and less or equal to 78 letters in the study eye and, inclusively, using ETDRS- like visual acuity testing charts at a testing distance of 4 meter (approximate Snellen equivalent of 20/32 to 20/320) at screening.
- •* Concomitant conditions in the study eye which, in the opinion of the investigator, do not prevent improvement of visual acuity on study treatment
排除标准
- •see also protocol 4.4
研究者
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