NCT01607190已完成不适用
Biomarkers of Diabetic Retinopathy Progression.
Association for Innovation and Biomedical Research on Light and Image2 个研究点 分布在 2 个国家目标入组 200 人开始时间: 2012年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- CSME needing treatment either photocoagulation or ITV.
研究概览
简要总结
The purpose of this study is to validate a predictive model of diabetic retinopathy progression in patients with diabetes mellitus type 2 patients to clinically significant macular edema (CSME) needing treatment either photocoagulation or intravitreal injections (ITV) using non-invasive techniques.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
- •Age over 35 years-old
- •Non-proliferative diabetic retinopathy (Levels 20 to 35, according the ETDRS criteria)
- •Best Corrected Visual Acuity > 20/25 on the ETDRS chart
- •Informed Consent
排除标准
- •Previous laser therapy
- •Other retinal vascular disease
- •Recent intraocular surgery (in the last 6 months)
- •Inadequate ocular media and/ or pupil dilatation that do not permit good quality fundus photography (e.g. cataract)
- •HbA1C > 11 % at the Screening
- •Subject that has a condition or that is in a situation which may put him/her at significant risk, may confound the study results or may interfere significantly with his/ her participation in the study.
结局指标
主要结局
CSME needing treatment either photocoagulation or ITV.
时间窗: Months 0, 6, 12 and 24.
次要结局
- Best corrected visual acuity.(Months 0, 6, 12 and 24.)
- Vision loss of at least 2 lines documented in ETDRS charts(Months 0, 6, 12 and 24.)
- Central retinal thickness(Months 0, 6, 12 and 24.)
- Microaneurysm(MA) activity (number of MA, MA formation and MA disappearance rates and MA turnover)(Months 0, 6, 12 and 24.)
研究者
研究点 (2)
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