ISRCTN99870008
暂停
未知
Prospective multicentre discovery and validation of diagnostic circulating biomarkers to detect sight-threatening diabetic retinopathy
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- Diabetic retinopathy
- 发起方
- Moorfields Eye Hospital NHS Foundation Trust
- 入组人数
- 538
- 状态
- 暂停
- 最后更新
- 3年前
概览
简要总结
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35511139/ (added 28/06/2022)
研究者
入排标准
入选标准
- •1\. Adults \> 40 years of age
- •2\. Ability to give informed consent
- •3\. Patient has to meet ONLY ONE of the criteria below to be included in this study:
- •3\.1\. Patient is not diabetic
- •3\.2\. Patient is Type 2 DM for \> 5 years but no diabetic retinopathy in both eyes
- •3\.3\. Mild/Moderate/Severe NPDR with DMO defined as morphological OCT evidence of macular oedema in the worse eye in the last 12 months
- •3\.4\. Active PDR with or without diabetic macular oedema in the worse eye (newly diagnosed treatment naïve or being treated with PRP and/or VR surgery in the last 2 years)
排除标准
- •1\. Type 1 Diabetes Mellitus
- •2\. Type 2 Diabetes Mellitus \< 5 years with no diabetic retinopathy
- •3\. Comorbidities such as liver disease, malignancy, acute infections, inflammatory processes, recent surgeries
- •4\. Blood pressure systolic \> 180 mmHg or diastolic \> 110 mmHg
- •5\. Pregnant and breast feeding women
- •6\. Patient on corticosteroids or immunosuppression
- •7\. Major ocular conditions like uveitis, glaucoma, AMD, vasculitis, occlusion etc in either eye
- •8\. Any ocular conditions other than diabetic retinopathy/maculopathy affecting vision in either eye – for e.g. epiretinal membrane, vitreomacular traction etc
- •9\. Cataract surgery or any ocular surgery in the last 3 months in either eye
- •10\. Significant cataract affecting adequate fundus photographs in either eye
结局指标
主要结局
未指定
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