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NCT Number: NCT07351786

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

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.

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Key information

Conditions

Diabetes (DM) Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Diabetic Retinopathy (DR) Diabetic Retinopathy Associated with Type 2 Diabetes Mellitus Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Retinal Diseases Retinopathy, Diabetic Vascular Diseases

Age range

25 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alexandria University Main Hospitals - Diabetes clinics/ Ophthalmology clinics

Alexandria, Egypt

Location status: Recruiting

About this study

This is a Cross-Sectional Study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The level of diabetic retinopathy, measured using Optos Ultra-widefield (UWF) Retinal Imaging, reported as ICDR (International Clinical Diabetic Retinopathy) score (0-4 scale).

    Time frame: 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 outcomes

  1. Glycemic control measured by HbA1c level using a standardized laboratory analyzer and reported in %.

    Time frame: Assessed once per participant at baseline.

  2. Renal function measured by serum creatinine level using a standardized laboratory analyzer and reported in mg/dL.

    Time frame: Assessed once per participant at baseline.

  3. Kidney damage status measured by UACR (Urine Albumin-to-Creatinine Ratio) using a standardized laboratory assay and reported as mg/g.

    Time frame: Assessed once per participant at baseline.

Study contacts

Contact information is provided by the study sponsor or research team.

Sara A Belal

CONTACT

[email protected]

+201554630615

Sponsors and collaborators

Lead sponsor

Sara A Belal

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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