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

January 12, 2026 updated by: Sara A Belal
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This is a Cross-Sectional Study

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Recruiting
        • Alexandria University Main Hospitals - Diabetes clinics/ Ophthalmology clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients are recruited from Ophthalmology and Diabetes clinics from Alexandria University Main Hospitals.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Classical Oral Anti-Diabetic Drugs
New-generation Oral Antidiabetic Drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed once per participant at baseline.

Secondary Outcome Measures

Outcome Measure
Time Frame
Glycemic control measured by HbA1c level using a standardized laboratory analyzer and reported in %.
Time Frame: Assessed once per participant at baseline.
Assessed once per participant at baseline.
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.
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.
Time Frame: Assessed once per participant at baseline.
Assessed once per participant at baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sara A Belal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

December 18, 2025

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0108753

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Biochemical analysis and images could be shared (Anonymous)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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