NCT03385382已完成不适用
Macular Thickness and Vessel Density Changes After Dexamethasone Implant and Ranibizumab Intravitreal Injection in Diabetic Macular Edema: 6-month Follow-up
G. d'Annunzio University0 个研究点目标入组 40 人开始时间: 2016年12月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Central macular thickness
研究概览
简要总结
Between December 2016 and June 2017 a total of 40 eyes from 40 diabetic retinopathy patients with diabetic macular edema were recruited at the Ophthalmologic Clinic of University "G. d'Annunzio", Chieti-Pescara, Italy.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years old
- •BCVA greater than 0.5 LogMAR in the study eye at baseline examination
- •Presence of recent DME
- •CMT > 300µm as measured using the SD-OCT at the baseline examination
排除标准
- •Any previous ocular surgery in the last 6 months
- •Laser treatments
- •Prior ocular trauma
- •Retinal vascular diseases
- •Vitreo-retinal interface diseases
- •Medium lens opacities (according to Lens Opacities Classification System)
研究组 & 干预措施
Dexamethasone group
Patients with diabetic macular edema receiving dexamethasone
干预措施: Dexamethasone intravitreal implant 0.7 mg (Drug)
ranibizumab
Patients with diabetic macular edema receiving ranibizumab
干预措施: Ranibizumab Injection (Drug)
结局指标
主要结局
Central macular thickness
时间窗: 6 months
Decrease of macular thickness
次要结局
- visual acuity(6 months)
研究者
LISA TOTO
Researcher
G. d'Annunzio University
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