NCT04038125Unknown4 期
Increase in Capillary Plexus Density Level Following the Use of Ozurdex for the Treatment of DME (RMSM ICOD STUDY)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluate re perfusion following Ozurdex use.
研究概览
简要总结
The objective of this study is to test the hypothesis that following the use of intravitreal dexamethasone implant for the treatment of DME, there will be an observable increase in the capillary density plexus as denoted by the quantitative assessment of the superficial capillary plexus on OCTA, as well as a decrease in size of the foveal avascular zone (FAZ).
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and Older.
- •Diagnosis of diabetes mellitus (type 1 or type 2).
- •At least one eye meets the study eye criteria listed.
- •Visual Acuity 20/30 - 20/200 Snellen equivalent
- •Have received no previous treatment for diabetic macular edema,(treatment naïve)
- •Mild to Severe Non-proliferative Diabetic Retinopathy
- •Diabetic macular edema present on optical coherence tomography (OCT) central subfield: ≥ 300µm.
- •Able and willing to provide informed consent.
排除标准
- •Have had any prior ocular treatment.
- •Have had prior retinal surgical ( i.e. Pars plana vitrectomy). 3 .Have any clinical evidence of proliferative diabetic retinopathy.
- •Have a HBA1c of greater of 10%.
- •Evidence of Glaucoma or who are labeled glaucoma suspect at screening (defined as C/D >/= 0.5 with correlated NFLA thinning or IOP>25mmHg).
- •Have a contraindication to Ozurdex.
研究组 & 干预措施
Ozurdex Implant
Other
Intravitreal injection of Ozurdex implant
干预措施: Ozurdex Drug Implant Product (Drug)
结局指标
主要结局
Evaluate re perfusion following Ozurdex use.
时间窗: 6 Months
Determined by OCT-A
次要结局
未报告次要终点
研究者
Diana Shechtman, OD FAAO
Principal Investigator - OD, FAAO
Retina Macula Specialists of Miami, LLC
研究点 (1)
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