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临床试验/CTRI/2018/03/012383
CTRI/2018/03/012383已完成不适用

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.

AIIMS1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年7月10日最近更新:

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)

研究者

发起方
AIIMS
申办方类型
Government medical college

研究点 (1)

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