Prospective multicentre discovery and validation of diagnostic circulating biomarkers to detect sight-threatening diabetic retinopathy

Moorfields Eye Hospital NHS Foundation Trust0 个研究点目标入组 538 人开始时间: 2018年10月23日最近更新: 2022年8月5日

适应症

试验速览

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35511139/ (added 28/06/2022)

•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)

•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)

发起方