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

NCT07351786 | Recruiting

• 1 other identifier: 0108753
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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).

  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 Outcomes (3)

• 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.

Study Arms (2)

Classical Oral Anti-Diabetic Drugs

New-generation Oral Antidiabetic Drugs

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sara A Belal: lead

Study Sites (1)

Alexandria University Main Hospitals - Diabetes clinics/ Ophthalmology clinics

Alexandria, Egypt

RECRUITING

Related Publications (4)

• Solomon SD, Chew E, Duh EJ, Sobrin L, Sun JK, VanderBeek BL, Wykoff CC, Gardner TW. Diabetic Retinopathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Mar;40(3):412-418. doi: 10.2337/dc16-2641. No abstract available.

  PMID: 28223445 BACKGROUND

• O'Hara DV, Lam CSP, McMurray JJV, Yi TW, Hocking S, Dawson J, Raichand S, Januszewski AS, Jardine MJ. Applications of SGLT2 inhibitors beyond glycaemic control. Nat Rev Nephrol. 2024 Aug;20(8):513-529. doi: 10.1038/s41581-024-00836-y. Epub 2024 Apr 26.

  PMID: 38671190 BACKGROUND

• Nentwich MM, Ulbig MW. Diabetic retinopathy - ocular complications of diabetes mellitus. World J Diabetes. 2015 Apr 15;6(3):489-99. doi: 10.4239/wjd.v6.i3.489.

  PMID: 25897358 BACKGROUND

• Chawla A, Chawla R, Jaggi S. Microvasular and macrovascular complications in diabetes mellitus: Distinct or continuum? Indian J Endocrinol Metab. 2016 Jul-Aug;20(4):546-51. doi: 10.4103/2230-8210.183480.

  PMID: 27366724 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine, Plasma, Serum

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications

Central Study Contacts

Sara A Belal

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Demonstrator at Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Alexandria University

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 20, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)