Intravitreal Diclofenac Versus Intravitreal Ranibizumab for the Treatment of Diabetic Macular Edema.
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in central macular thickness
研究概览
简要总结
The study aims to compare the effect of intravitreal non steroidal anti inflammatory (Diclofenac) versus the standard treatment of diabetic macular edema, intravitreal anti vascular endothelial growth factor (Ranibizumab), measuring central macular thickness changes and best corrected visual acuity.
详细描述
Thirty eyes of diabetic patients with diabetic retinopathy with macular edema will be randomized using simple randomization method into two groups; A and B.
Group A will undergo intravitreal injection of 500µg Diclofenac, repeated monthly for 3 months. Electroretinogram will be performed before the injections, 4 weeks after first injection and 4 weeks after third injection to assess any risk of toxicity.
Colored photography and fundus fluorescein angiography will be done before the first injection to assess the extent of macular leakage at late phases, and to exclude cases with macular ischemia.
Optical coherence tomography will be done to measure the central macular thickness, before the first injection, and before each injection.
Visual acuity will be assessed before and after each injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic retinopathy with non tractional maculopathy, where central macular thickness is greater than 400µm, with and without cystic changes.
- •Diabetes Mellitus type one and two
- •Best Corrected Visual Acuity > 0.1 LogMar
排除标准
- •Patients treated with diclofenac, Ranibizumab or Bevacizumab in the past 3 months
- •Patients with a history of branch or central retinal artery occlusion
- •Patients without clear media and adequate pupillary dilation that allows proper fundoscopy and imaging, and patients who are not complaint with the regular visits.
- •Visual Significant Cataract
- •Evidence of vitreomacular traction or macular ischemia
研究组 & 干预措施
Group A
15 eyes will receive 0.1 ml containing 500µg of diclofenac intravitreally, repeated monthly for 3 months.
干预措施: Diclofenac Sodium 0.1 ml containing 500µg (Drug)
Group B
15 eyes will receive 0.5 mg Ranibizumab intravitreally, repeated monthly for 3 months.
干预措施: Ranibizumab 0.5 mg Solution for Injection (Drug)
结局指标
主要结局
Change in central macular thickness
时间窗: 3 months of follow up
Measuring the change in central macular thickness using Optical Coherence Tomography
Change in best corrected visual acuity
时间窗: 3 months of follow up
Measuring the best corrected visual acuity
次要结局
未报告次要终点
研究者
Iyad Adnan Salem Goussous
Doctor Iyad Adnan Salem Goussous
Cairo University