Observational Study of Type-2 Diabetic Subjects to Validate Diabetic Retinopathy Phenotypes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- CSME
研究概览
简要总结
The purpose of this study is to validate and characterize phenotypes of diabetic retinopathy (DR) progression based on available clinical data (demographic, systemic and ophthalmic data).
详细描述
This study aims to validate and characterize phenotypes of diabetic retinopathy (DR) progression using ophthalmic and systemic data from type-2 diabetic subjects followed at the AIBILI Clinical Trial Center in the last 10 years.
Macular Edema (ME) development during the study period, mainly Clinically Significant ME (CSME) needing treatment, will be the primary indicator for DR progression. CSME will be considered as the primary end-point and will be used to identify phenotypes (and risk markers) of DR progression.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Diagnosis of DR.
- •Females or Males;
- •Age over 18 years;
- •Signed Informed Consent;
- •Previous follow-up with regular systemic and ophthalmic assessments.
排除标准
- •Cataract or other eye disease that may interfere with fundus examinations;
- •Vitreous syneresis or posterior vitreous detachment;
- •Dilatation of the pupil < 5 mm.
结局指标
主要结局
CSME
时间窗: 1 year
次要结局
未报告次要终点
