A prospective interventional study to find the effectivity of Razumab by measuring macular edema pre and post intravitreal injection.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- 1.the percentage of reduction of macular edema after 4 weeks.
研究概览
简要总结
The visual acuity, intraocular pressure, anterior segment examination with slitlamp,microscope is done. Retinal examination is done with indirect ophthalmoscopy after dilating the pupils with Tropicamide 0.8% and phenylephrine 5%. Optical coherence tomography (OCT) is done to measure the macular edema. antivascular endothelial growth factor biosimilar Razumab 0.5mg in 0.05ml is given intravitreally under strict aseptic precuations. Patients are followed up after 1 week and then after 4 weeks.The best corrected visual acuity is recorded with LogMAR chart and the macular thickness measured with OCT. 2 tailed paired T test will be used to find the difference between pre and post single dose of intravitreal Razumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •patients with diabetic macular edema or macular edema due to retinal vaso-occlussive disease with central macular thickness of less or equal to 315 micron and visual acuity of less or equal to 0.2 on LogMAR chart will be included in the study.
排除标准
- •pre existing macular scar or dystrophy.
- •2.patients with active inflammatory and infectious diseases of the eye.
- •Patients already under treatment for macular edema in other hospital.
- •4.patients with history of recent ocular history or trauma.
- •patients with history of cerebrovascular or cardiovascular comorbidities.
结局指标
主要结局
1.the percentage of reduction of macular edema after 4 weeks.
时间窗: 1.the percentage of reduction of macular edema after 4 weeks.
次要结局
- improvement in best corrected visual acuity after 4 weeks of injection of intravitreal Razumab(1.visual acuity and macular edema will be measured before the intravitreal antivegf injection.)