ISRCTN99870008暂停未知
Prospective multicentre discovery and validation of diagnostic circulating biomarkers to detect sight-threatening diabetic retinopathy
适应症
试验速览
- 阶段
- 未知
- 状态
- 暂停
- 入组人数
- 538
研究概览
简要总结
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35511139/ (added 28/06/2022)
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
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
- •11. Mild/Moderate/Severe NPDR without DMO in worse eye (study eye)
研究者
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