prospective randomized interventional trial comparing branch retinal vein occlusion treatment with ultra wide field imaging guided peripheral laser in combination with ranibizumab vs ranibizumab only in treatment naive cases.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AIIMS
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- BCVA ( snellens visual acuity and ETDRS)
研究概览
简要总结
Branch retinal vein occlusion is a leading cause of vision loss. Treatment with ranibizumab (vascular endothelial growth factor (VEGF) inhibitor) on a monthly basis has been associated with improved vision results. There is a subgroup of patients with peripheral nonperfusion on ultrawidefield angiography that appears to be more dependent on anti-VEGF treatment.
In this trial the investigators compare the gold standard of monthly ranibizumab injections with ranibizumab + peripheral scatter laser to the areas of nonperfusion on angiography. Each group will have monthly injections for the first 3 months, then as needed by either visual acuity decrease or increased retinal thickness for the subsequent 3 months.
The primary outcome is visual acuity. Secondary outcomes are reduction in optical coherence tomography, and number of ranibizumab injections
The purpose of the study is to assess whether peripheral scatter laser has any role in decreasing the macular edema in BRVO patients in addition to anti-VEGF ( Ranibizumab ).
Ultrawidefield FA reveals correlation between non perfusion in the peripheral retina with macular edema and retinal neovascularisation. The study hypothesis is to determine if laser photocoagulation of the non perfused retina decreases macular edema and neovascularisation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Diagnosed case of BRVO with macular edema with evidence of capillary non perfusion 2.Macular edema involving center of fovea 3.BCVA at baseline- 3/60-6/18 by Snellen’s visual acuity 4.Mean central subfield thickness > 300 micrometer by OCT at baseline visit 5.Informed consent 6.Media clarity, pupillary dilatation and patient cooperation sufficient for fundus photography.
排除标准
- •other ocular diseases like AMD eyes, diabetic retinopathy, disc pallor
- •recent CVA, MI or major ischemic event 3 months preceding baseline visit
- •known sensitivity to any anti-VEGF drugs and sodium fluorescein
- •previous macular or pan retinal photocoagulation 5.previous anti-VEGF treatment 6.no consent 7.patient not willing for follow up.
结局指标
主要结局
BCVA ( snellens visual acuity and ETDRS)
时间窗: 1 month, 3 months, 6 months
次要结局
- OCT(number of ranibizumab injections)
