NCT03475407Unknown4 期
The Effects of Intravitral Ozurdex Implant in DME: Cytokine Change in Aqueous Humor
Nune Eye Hospital, Seoul, Korea1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes of Central foveal thickness(CFT, height in micrometers)
研究概览
简要总结
Intravitreal Ozurdex implant therapy improves visual outcome and OCT findings. The purpose of this study is that these results are correlated with the change of cytokine level known to be increased in DME patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients of Type 1 or Type 2 Diabetes Mellitus fulfilling the following inclusion criteria shall be enrolled in the study:
- •Patients of Non Proliferative Diabetic Retinopathy(NPDR) with clinically significant macular edema(CSME)
- •Patients with Proliferative Diabetic Retinopathy(PDR) with CSME where proliferative component has been adequately treated with laser photocoagulation
- •Diabetic patients with cystoids macular edema
- •Minimum central thickness on OCT not less than 300 microns
- •BCVA 20/30~20/320
排除标准
- •Patients with history of Anti-VEGF or steroid injection, any type of laser treatments, vitrectomy, cataract surgery within 6 months
- •Patients with history of ocular hypertension or glaucoma
- •Patients with media haze or pupillary non-dilation that does not allow good fundus photography, FFA and OCT
- •Patients with macular ischemia on FFA
- •Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva
- •Patients whose posterior lens capsule is not intact.
- •patients with known hypersensitivity to any components of this product.
- •patients with vitreous hemorrhage
- •patients who have systemic treatment effect on study results
- •patients who enrolled other clinical study
研究组 & 干预措施
Treatment Group
Experimental
Ozurdex intravitreal injection
干预措施: Ozurdex intravitreal injection (Drug)
结局指标
主要结局
Changes of Central foveal thickness(CFT, height in micrometers)
时间窗: Baseline, 1 week, 6 weeks, 12 weeks, 18 weeks, 24 weeks
次要结局
- Changes of aqueous humor cytokine (VFGF, IL-2, IL-6,IL-8, MCP-1)(Baseline, 6 weeks, 18 weeks)
- Changes of Best corrected Visual acuity(BCVA, ETDRS scale)(Baseline, 1 week, 6 weeks, 12 weeks, 18 weeks, 24 weeks)
研究者
Oh Woong Kwon
Chief of retina center in Nune Eye Hospital
Nune Eye Hospital, Seoul, Korea
研究点 (1)
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