Randomized Clinical Trial to Evaluate the Effect of Dapagliflozin in Patients with Diabetic Macular Edema

Last updated: February 20, 2025
Sponsor: Alexandria University
Overall Status: Active - Recruiting

Phase

2

Condition

Diabetic Macular Edema

Diabetic Retinopathy

Macular Edema

Treatment

Dapagliflozin

Anti-VEGF drug

Clinical Study ID

NCT06845163
0202071
  • Ages 18-85
  • All Genders

Study Summary

The purpose of this clinical study is to explore the efficacy of dapagliflozin as an adjunct to intravitreal anti-vascular endothelial growth factor (anti-VEGF) for enhanced reduction of retinal thickness and vision improvement in patients with diabetic macular edema. The main question the study aims to answer is: Does dapagliflozin reduce the thickness of the macula when combined with the standard of care intravitreal anti-VEGF therapy more than the intravitreal anti-VEGF therapy alone?

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Type II diabetes mellitus (DM) adult patients, on premixed insulin and metformin,who are diagnosed with center-involved diabetic macular edema (ci-DME)

Exclusion

Exclusion Criteria:

  • Patients below 18 years old

  • Patients with type I diabetes mellitus (Insulin dependent diabetes mellitus IDDM)

  • Pregnant and lactating women

  • Patients with other causes of macular edema such as retinal vein occlusion

  • Patients who had previous macular laser treatment in the affected eye

  • Patients who had previous peripheral panretinal photocoagulation laser (PRP)treatment in the affected eye during the past 6 months

  • Patients who had been treated with intravitreal anti-VEGF injections in the affectedeye during the past 6 months

  • Patients who had myocardial infarction within 3 months of recruitment

  • Patients who had stroke within 3 months of recruitment

  • Patients with severe hepatic impairment of Child-Turcotte-Pugh class C

  • Patients treated with antidiabetic drugs thiazolidinediones (TZD) (rosiglitazone andpioglitazone)

  • Patients already on SGLT2 inhibitor drugs (dapagliflozin, canagliflozin, orempagliflozin) before recruitment

  • Patients on topical prostaglandin analogs (e.g., latanoprost, travoprost, ioprost,and tafluprost)

  • Patients diagnosed with ocular surface infections until treated

Study Design

Total Participants: 56
Treatment Group(s): 2
Primary Treatment: Dapagliflozin
Phase: 2
Study Start date:
February 08, 2025
Estimated Completion Date:
August 31, 2026

Study Description

Some evidence in the literature suggests that sodium glucose co-transporter 2 (SGLT2) inhibitors may be beneficial in reducing diabetic macular edema. The objective of this clinical trial is to investigate the efficacy and safety of dapagliflozin when combined with intravitreal aflibercept injections in the management of patients with type II diabetes mellitus and center-involved diabetic macular edema (ci-DME). This randomized, double-blind, parallel group, active control design, clinical trial, is investigating the effect of oral dapagliflozin 10 mg given once daily in addition to intravitreal aflibercept versus intravitreal aflibercept alone on reducing macular central subfield thickness (CST) and improving visual acuity in diabetic patients with ci-DME.

Connect with a study center

  • Alexandria Main University Hospital, The Ophthalmology Department, Faculty of Medicine, Alexandria University

    Alexandria,
    Egypt

    Active - Recruiting

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