NCT01440660已完成不适用
Phenotypes of Nonproliferative Diabetic Retinopathy in Diabetes Type 2 Patients Identified by Optical Coherence Tomography, Colour Fundus Photography, Fluorescein Leakage and Multifocal Electrophysiology (DIAMARKER Project: Genetic Susceptibility for Multi-systemic Complications in Diabetes Type-2: New Biomarkers for Diagnostic and Therapeutic Monitoring).
Association for Innovation and Biomedical Research on Light and Image1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年1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
- 20
- 试验地点
- 1
- 主要终点
- Multimodal testing/imaging procedures - Brain Imaging
研究概览
简要总结
To characterise phenotypes of Non Proliferative Diabetic Retinopathy (NPDR) progression using multimodal testing/imaging procedures.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years-old.
- •Diabetes mellitus type 2 according to 1985 WHO criteria.
- •Non-proliferative diabetic retinopathy (ETDRS level <= 35)
- •Signs of NPDR progression based on existing clinical information:
- •Retinal thickness (RT) increase (increase in RT above normal range as measured by OCT, considering the macular thickness normative data) in the central subfield, the inner ring and/or the outer ring (leaking phenotype); OR
- •Neovascular disease activity as shown by microaneurysms (MA) turnover (MA formation rate >= 2, i.e. number of new MA per year) computed from CFP using the RetmarkerDR software (ischemic phenotype).
- •Informed consent.
排除标准
- •Cataract or other eye disease that may interfere with fundus examinations
- •Any eye surgery or treatment within a period of 6-months.
- •Pregnant or nursing (lactating) women.
- •Patients with chronic or severe kidney disease (glomerular filtration rate, GFR < 30 mL/min/1.73m2).
- •Patients with acute kidney injury.
- •Patients with known allergic or hypersensitivity reactions to gadolinium, versetamide or any of the inert ingredients.
- •Patients around the time of liver transplantation..
- •Patients with implants containing metals.
结局指标
主要结局
Multimodal testing/imaging procedures - Brain Imaging
时间窗: 12 months
Metabolite concentrations assessed with MR Spectroscopy.
Multimodal testing/imaging procedures - Ophthalmological Imaging
时间窗: 12 months
Blood-Brain Barrier alterations assessed contrast agent with Dynamic MR.
Multimodal testing/imaging procedures - Psychophysical Testing
时间窗: 12 months
Psychophysical tests for speed discrimination, achromatic contrast, and chromatic contrast.
Multimodal testing/imaging procedures - Barin Imaging
时间窗: 12 months
Perfusion change measured with ASL.
次要结局
- Multimodal testing/ imaging modalities (raw data)(24 months)
研究者
研究点 (1)
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