Comparison of Therapeutic Effects Between Intravitreal Injection of Bevacizumab With Intravitreal Injection of Bevacizumab and Targeted Laser Photocoagulation of Non Perfused Areas of Retina in Patients With Acute Retinal Vein Occlusion
试验速览
- 阶段
- 2 期
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Visual acuity
研究概览
简要总结
Patients with new onset retinal vein occlusion in less than 3 month whom has visual acuity less than 20/40 and central macular thickness more than 250micrometer and non perfused areas of retina more than 10 DD are included in over study and devided into 2 groups randomizely, Group A under gone 3 intravitreal injection of bevacizumab monthly and examine monthly for Visual acuity and central macular thickness, if in month four or more the CMT is more than 250 micrometer and the visual acuity is less than 8/10 the injection is repeated and follow up in this manner is continued until 9 months.
Group B is as the same of group A but patients in this group undergone laser photocoagulation of retinal non perfused areas based on FAG wide field imaging .
After 9 month follow up the outcomes such as Vusal acuity, Central macular thickness, intraocular pressure, neovascular formation are compared,
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Center-involved macular edema secondary to RVO on clinical exam
- •Symptoms less than 3 months
- •BCVA= 20/40 or worse
- •Mean center point thickness >250 μm
- •Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs
- •One eye per participant is enrolled in the trial
排除标准
- •Macular edema due to a cause other than CRVO
- •An ocular condition such that visual acuity would not improve from resolution of the edema (eg, foveal atrophy)
- •Substantial cataract estimated to have reduced visual acuity by >3 lines
- •Prior treatment with intravitreal or peribulbar steroid injection
- •History of macular photocoagulation or PRP
- •Prior pars plana vitrectomy
- •Hx of Intraocular surgery (including cataract extraction)
- •uveitis, NVG, exudative AMD, diabetic retinopathy, any malignancy, optic neuropathy, amblyopia
- •vitreomacular traction or epiretinal membrane *uncontrolled glaucoma ( > 30mmHg with anti-glaucoma medications)
研究组 & 干预措施
intravitreal injection of bevacizumab
干预措施: intravitreal injection of bevacizumab (Drug)
intravitreal injection of bevacizumab+ targeted laser
Intervention intravitreal bevacizumab injection + targeted laser photocoagulation of retinal non perfused areas
干预措施: intravitreal injection of bevacizumab+ targeted laser (Radiation)
结局指标
主要结局
Visual acuity
时间窗: Every month
Snellen chart
次要结局
- macular thickness(every month)
研究者
Zahra Rabbani Khah
Clinical Professor
Shahid Beheshti University of Medical Sciences