Intravitreal dexamethasone implant (ozurdex) in the management of treatment naive diabetic macular edema
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
Hamna Asharaf
Sankara eye hospital
