PROGRESS - Progression of Diabetic Retinopathy. Identification of Signs and Surrogate Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Phenotypic classification of DR in a 5-year period
研究概览
简要总结
Progression of Diabetic Retinopathy. Identification of Signs and Surrogate outcomes (PROGRESS)
详细描述
The global aim of this study is to improve the current knowledge of diabetic retinopathy (DR) progression. We aim to characterize both functionally and morphologically initial DR stages and to identify patients at risk of progression to centre involving macular oedema (CME) and/or proliferative diabetic retinopathy (PDR). We want to identify imaging patterns and characteristics that might be used as prognostic biomarkers for DR progression.
For this, ischemia and blood-retinal barrier alteration will be assessed using non-invasive retinal imaging methodologies. SD-OCT with layer-by-layer segmentation will be performed. Furthermore, a state-of-the-art methodology with OCT-Angiography will be used for identification of areas of capillary drop-out and leakage areas will be identified on SD-OCT without the need of a dye injection. In a subgroup of patients we will study neurodegeneration patterns using multifocal ERG examination.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus according to 1985 WHO criteria
- •Aged between 35 years and 80 at baseline in the retrospective period
- •NPDR level < 20 (MA absent) or Mild NPDR (levels 20 to 35, based on ETDRS criteria- 7 fields CFP) at baseline
- •BCVA ≥ 75 letters (≥ 20/32) at baseline (ETDRS charts)
- •Informed Consent
排除标准
- •Inadequate ocular media and/ or pupil dilatation that interfere with fundus examinations
- •HbA1C > 10 % at the Screening or previous 6 months in the previous prospective study
结局指标
主要结局
Phenotypic classification of DR in a 5-year period
时间窗: 5 years
Presence CME (Central Macular Edema) or PDR (Proliferative Diabetic Retinopathy)
次要结局
- DR severity level(5 years)
- Retinal thickness analysis(5 years)
- Ellipsoid zone analysis(5 years)
- Choroidal thickness analysis(5 years)
- SD- OCT- Angiography analysis(5 years)
- OCT-Leakage analysis(5 years)
- Retinal thickness quantification(5 years)
- mfERG assessement(5 years)