Impact of the New Generation Anti-diabetic Drugs on Diabetic Retinopathy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07351786

Enrollment

Registered

2026-01-20

Start date

2025-08-01

Completion date

2026-09-01

Last updated

2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes (DM), Diabetic Retinopathy Associated With Type 2 Diabetes Mellitus, Diabetic Retinopathy (DR), Retinopathy, Diabetic

Brief summary

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.

Detailed description

This is a Cross-Sectional Study

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

25 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* Gestational Diabetes * Type 1 Diabetes * Severe non-proliferative diabetic retinopathy (NPDR) at baseline * Proliferative diabetic retinopathy (PDR) at baseline * Pregnant and breastfeeding women

Design outcomes

Primary

Measure	Time frame	Description
The level of diabetic retinopathy, measured using Optos Ultra-widefield (UWF) Retinal Imaging, reported as ICDR (International Clinical Diabetic Retinopathy) score (0-4 scale).	Assessed once per participant at baseline.	Where 0 indicates no apparent diabetic retinopathy and 4 indicates proliferative diabetic retinopathy; higher scores indicate more severe (worse) diabetic retinopathy.

Secondary

Measure	Time frame
Glycemic control measured by HbA1c level using a standardized laboratory analyzer and reported in %.	Assessed once per participant at baseline.
Renal function measured by serum creatinine level using a standardized laboratory analyzer and reported in mg/dL.	Assessed once per participant at baseline.
Kidney damage status measured by UACR (Urine Albumin-to-Creatinine Ratio) using a standardized laboratory assay and reported as mg/g.	Assessed once per participant at baseline.

Countries

Egypt

Contacts

CONTACTSara A Belal

phar-sara.belal@alexu.edu.eg+201554630615

Outcome results