Evaluation of risk factors for the development of diabetic retinopathy (DR) in patients with type 2 diabetes: comprehensive analysis with optical coherence tomography (OCT), VEGF and biomarkers of inflammatio
- Conditions
- MedDRA 10012689MedDRA 10012688
- Registration Number
- DRKS00027805
- Lead Sponsor
- GWT TUD GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 32
• Written informed consent
• Patients with type 2 diabetes mellitus (T2DM) for whom datasets from the previous studies are available
• Ability to understand and follow study-related instructions
• Acute infection within 14 days prior to screening
• Acute inflammatory disease within 14 days prior to screening or current chronic inflammatory disease
• Pre-existing autoimmune disease
• Treatment with immune suppressive drugs within 14 days prior to screening
• Systemic treatment with glucocorticoids within 14 days prior to screening
• Myocardial infarction or stroke within 1 year before inclusion
• Surgeries (including intravitreal injections) within the previous 3 months
• Oncological disease within the previous 5 years
• Women who are pregnant or breast-feeding
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this observational study is to determine the prognostic value of traditional and new risk factors for development of DR and progression of DME, respectively.
- Secondary Outcome Measures
Name Time Method Secondary objectives of the study are to<br>• investigate the impact of quality of diabetes and risk factor control on development of FRT<br>• identify high-risk groups for FRT and DR<br>• develop a guide for OCT diagnostics in managed care programs