跳至主要内容
临床试验/CTRI/2024/10/075960
CTRI/2024/10/075960尚未招募不适用

Intravitreal dexamethasone implant (ozurdex) in the management of treatment naive diabetic macular edema

Hamna Asharaf1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Improvement in BCVA assessed by Snellens chart

研究概览

简要总结

Patients with diabetes develop endothelial dysfunction which causes leakage of retinal microvasculature. The elevated pro- inflammatory cytokines and reduced anti inflammatory cytokines predispose to extravasation of fluid from the retinal vessels leading to diabetic macular edema. Initially, laser photo-coagulation was the mainstay of treatment, but it has limited effect in restoring vision. Anti-VEGF, although found effective, has the disadvantage of requiring frequent injection and follow up. Intra-vitreal corticosteroid implant overcomes the disadvantage of frequent dosing and the associated frequent injection related complications .Dexamethasone is a corticosteroid and has actions at the level of nucleus and gene expression. Corticosteroids prevents new vessel formation by suppressing angiogenic factors, including VEGF. It also increases the level of anti-inflammatory proteins. It maintains the integrity of tight junctions of the blood retinal barrier and also promotes clearance of retinal fluids. Ozurdex, containing 0.7mg dexamethasone, is biodegradable drug approved for treating diabetic macular edema and releases dexamethasone into the vitreous over a period of ≤6 month. This thesis evaluates the efficacy of dexamethasone intra-vitreal implant in the management of treatment naive diabetic macular edema.

研究设计

研究类型
Interventional

入排标准

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

入选标准

  • HbA1c less than or equal to 9g % Type 1 and Type 2 Diabetes Mellitus Age more than 40yrs Well controlled blood pressure.

排除标准

  • Previously treated Diabetic macular edema patients Other ocular comorbidities- glaucoma, ocular hypertension, ocular pathologies Previous retinal surgery History of previous intra-vitreal injection for any other ocular diseases.

结局指标

主要结局

Improvement in BCVA assessed by Snellens chart

时间窗: 1 week, 1 month and 3 months after surgery.

次要结局

  • Reduction in macular thickness as assessed by OCT(1 week, 1 month and 3 months after treatment.)

研究者

发起方
Hamna Asharaf
申办方类型
Other [self ]
责任方
Principal Investigator
主要研究者

Hamna Asharaf

Sankara eye hospital

研究点 (1)

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