About this trial
This study aims to test the impact of new-generation anti-diabetic drugs, such as SGLT2 inhibitors and DPP-4 inhibitors, on the development of diabetic retinopathy (DR). The study hypothesizes that these drugs have protective effects in diabetic retinopathy by delaying its incidence compared to older agents (including metformin) only. Early intervention is critical, as treatment options for advanced stages of DR are limited in terms of their ability to restore impaired vision and their high associated costs. By focusing on delaying the occurrence of diabetic retinopathy, the investigators aim to reduce the burden of DR and improve the quality of life for diabetic patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with Type 2 Diabetes for >5 years
Using Diabetes medications (metformin, sulfonylureas, SGLT2 inhibitors, DPP-4 inhibitors) for a period of 2-3 years
Disqualifiers
Gestational Diabetes
Type 1 Diabetes
Severe non-proliferative diabetic retinopathy (NPDR) at baseline
Proliferative diabetic retinopathy (PDR) at baseline
Trial population
Patients are recruited from Ophthalmology and Diabetes clinics from Alexandria University Main Hospitals.
Trial design
Other
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
The level of diabetic retinopathy, measured using Optos Ultra-widefield (UWF) Retinal Imaging, reported as ICDR (International Clinical Diabetic Retinopathy) score (0-4 scale).
Where 0 indicates no apparent diabetic retinopathy and 4 indicates proliferative diabetic retinopathy; higher scores indicate more severe (worse) diabetic retinopathy.
Secondary outcomes
Glycemic control measured by HbA1c level using a standardized laboratory analyzer and reported in %.
Renal function measured by serum creatinine level using a standardized laboratory analyzer and reported in mg/dL.
Kidney damage status measured by UACR (Urine Albumin-to-Creatinine Ratio) using a standardized laboratory assay and reported as mg/g.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sara A Belal
Lead sponsor
Alexandria University
Sponsor institution