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临床试验/NCT03821168
NCT03821168Unknown2 期

The Effect of Intravitreal Erythropoietin Injection for Refractive Diabetic Macular Edema

Shahid Beheshti University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2019年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
58
试验地点
1
主要终点
best corrected visual acuity

研究概览

简要总结

after advent of RD photoreceptor degeneration Occurred. This process appears as a incredible and progressive event that will not stop till reattachment of RPE and neurosensory retina happened .

Process of degeneration begins from first hours of RD establishment Neuroprotection of photoreceptor following RD is a novel and debatable discussion encountered in recent years .

How to stop this phenomena and neuroprotective agent role in this issue are a new interest of researches.

In the study investigators are planning to perform a clinical trial to demonstrate the minocycline neuroprotective effect in a double blind design as this impact has been implicated previously in a animal study.

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, Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patient with refractory diabetic macular edema at least one month after third injection

排除标准

  • previous vitreoretinal surgery previous glaucoma surgery glaucomatous patient open heart surgery active proliferative diabetic retinopathy one eye patients vitreous hemorrhage

研究组 & 干预措施

intravitreal injection of bevacizumab and erythropoietin

Active Comparator

erythropoietin:

干预措施: injection of bevacizumab and erythropoietin (Drug)

intravitreal injection of bevacizumab

Active Comparator

bevacizumab:1.25 mg

干预措施: injection of bevacizumab (Drug)

结局指标

主要结局

best corrected visual acuity

时间窗: 1 month

Snellen chart

次要结局

  • Optical coherence tomography(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zahra Rabbani Khah

Clinical Professor

Shahid Beheshti University of Medical Sciences

研究点 (1)

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