Circulating biomarkers to detect sight-threatening diabetic retinopathy
- Conditions
- Diabetic retinopathyEye Diseases
- Registration Number
- ISRCTN99870008
- Lead Sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Brief Summary
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35511139/ (added 28/06/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 538
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)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method