NCT01145599已完成不适用
Identifying Progression of Retinal Disease in Eyes With Non Proliferative Diabetic Retinopathy in Diabetes Type 2 Using Non-invasive Procedures
European Vision Institute Clinical Research Network1 个研究点 分布在 1 个国家目标入组 374 人开始时间: 2010年9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
- 374
- 试验地点
- 1
- 主要终点
- Identify "progressors"
研究概览
简要总结
The purpose of this study is to identify eyes that show worsening and disease progression (progressor phenotypes).
详细描述
To identify "progressors" in retinal vascular disease and central retinal edema in type 2 diabetic patients with early NPDR, based on retinal disease progression from baseline to the 12-month visit, assessed by the following biomarkers:
- Microaneurysms turnover (MA formation rate over or equal to 2, i.e. number of new MA from baseline to the 12-month visit) computed from color fundus photographs using the RetmarkerDR software; and
- Retinal thickness increase in eyes with retinal thickening (Increase in retinal thickness above normal range) in the central subfield, the inner ring and/or the outer ring Constantly Present, Present or Absent (as measured by OCT and considering the macula thickness normative data.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes type 2 according to 1985 WHO criteria
- •Age between 35 and 75 years
- •Mild non-proliferative diabetic retinopathy (levels 20 or 35, based on the ETDRS criteria) - 7 fields color fundus photography
- •Presence of at least 1 microaneurysm in the central 3000 micr. in diameter area (corresponding to 2 DA) - Field 2
- •Best Corrected Visual Acuity >= 75 letters (>= 20 /32)
- •Refraction with a spherical equivalent less than 5 Dp
- •Informed consent
排除标准
- •Cataract or other eye disease that may interfere with fundus examinations
- •Any eye surgery within a period of 6-months
- •Other retinal vascular disease
- •Previous laser therapy
- •Dilatation of the pupil < 5 mm
结局指标
主要结局
Identify "progressors"
时间窗: 12 months
To identify "progressors" in retinal vascular disease and central retinal edema, the following 2 biomarkers will be considered: the MA formation rate (biomarker for the progression of retinal vascular disease) and the presence of retinal thickening in the central subfield and/or the inner ring (biomarker for the presence of retinal edema).
次要结局
- Identify correlations between "progressors" and study outcomes.(12 months)
研究者
研究点 (1)
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