Menu
Recruiting NCT07351786

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Diabetes (DM), Retinopathy, Diabetic, Diabetic Retinopathy (DR), Diabetic Retinopathy Associated With Type 2 Diabetes Mellitus. Basic parameters: from 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Primary outcome measures

  • 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.]
Secondary outcome measures (3)
  • Glycemic control measured by HbA1c level using a standardized laboratory analyzer and reported in %. [Time frame: 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.]
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Egypt · 1 center
  • Alexandria University Main Hospitals - Diabetes clinics/ Ophthalmology clinics — Alexandria

Publications

  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07351786 · 0108753

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗