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临床试验/CTRI/2024/09/073550
CTRI/2024/09/073550已完成4 期

A Randomised Control Study To Compare The Efficacy Of Intravitreal Faricimab6.0 mg Versus Aflibercept 2.0 mg In Management of Treatment Naive Diabetic Macular Edema In Indian Population

Army Hospital Research And Referral1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年9月10日最近更新:

试验速览

阶段
4 期
状态
已完成
入组人数
72
试验地点
1
主要终点
To compare the efficacy of intravitreal faricimab 6.0mg vs aflibercept 2.0 mg in diabetic macular edema in Indian population

研究概览

简要总结

It will be a Randomised Controlled Study. The Study will be carried out at Department of Ophthalmology ,Army Hospital Research and Referral New Delhi . The study Population will be patients diagnosed with Diabetic Macular Edema . Diabetic Macular Edema stands as a significant Sight-Threatening complication of Diabetic Retinopathy, contributing substancially to the global burden of visual impairment. The aim of this study is to compare the Efficacy of Intravitreal Faricimab 6.0MG And Aflibercept 2.0MG in Treatment Naive Diabetic Macular Edema by observing the improvement in Best corrected Visual Acuity , reduction in Central Macular Thickness and to study whether Faricimab is able to achieve Longer Inter-injection Interval.Patients will be examined at 0,4 and 8 weeks and all patients meeting the inclusion criteria will receive loading doses as per the group in which they are assigned  and will be followed up at 4 weekly interval. Decision for Retreatment will be taken after 4 weeks of injection on the basis of worsening of Visual Acuity and Increase in Central Macular Thickness.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 18 years and above Piagnosed with Diabetic Macular Edema Patients willing to participate in study.

排除标准

  • Patients with other retinal diseases decreased visual acuity due to causes other than macular edema macular edema due to causes other than diabetes mellitus any form of central cataract in phakic patients posterior capsular opacity/iol subluxation in pseudophakic patients history of any uveitis, pregnant and lactating females.

结局指标

主要结局

To compare the efficacy of intravitreal faricimab 6.0mg vs aflibercept 2.0 mg in diabetic macular edema in Indian population

时间窗: follow up at zero week, then 4 week then every 4 weekly till 48 weeks.

次要结局

  • to compare efficacy of faricimab vs aflibercept in improving BCVA, reduction in Central macular thickness and inter injection interval .(follow up at zero week, then 4 week then every 4 weekly till 48 weeks.)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

PRADEEP KUMAR

Army Hospital RESEARCH AND REFERRAL

研究点 (1)

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