IRCT20170303032845N1招募中3 期
The Comparison of the Efficacy of Intravitreal Injection of Iranian Made Ranibizumab (Vicentis®) with Imported Ranibizumab (Lucentis®) in Patients with Diabetic Macular Edema: A phase III, Two-armed, Double-blind, Parallel, Active-controlled, and Noninferiority Clinical Randomized Trial
Aracell zist daru0 个研究点目标入组 154 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 154
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 years 至 80 years（—）
- 性别
- All
入选标准
- •Diabetes mellitus type 1 or 2
- •Center involving macular edema with a central subfield thickness (CST) of >300
- •Early treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity letter score of 24 to 78 (20/32 to 20/400)
- •Blood Pressure <150/100
- •Triglyceride and LDL up to 20% higher than upper normal limits
- •Pseudophakic patients are allowed to enter the study.
- •Signed written inform consent
排除标准
- •History of intravitreal injection within the past 2 months
- •History of any ocular surgery within the past 6 months
- •History of glaucoma or ocular hypertension
- •Any media opacity in the cornea, lens and vitreous body which interferes with eye examination and imaging.
- •Monocular patients
- •Pregnant or breastfeeding women
- •Proliferative diabetic retinopathy (PDR) with high-risk characteristics
- •Smoking (more than 10 cigarettes per day)
- •Use of acetazolamide tablets or intraocular pressure-lowering drops
- •Use of systemic corticosteroids or nonsteroidal anti-inflammatory eye drops (NSAIDs)
研究者
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