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

Phase 2

Recruiting

• Conditions: Diabetic Macular Edema; Center-involved Diabetic Macular Edema
• Interventions: Drug: Dapagliflozin; Drug: Anti-VEGF drug

• Registration Number: NCT06845163
• Lead Sponsor: Alexandria University

Brief 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?

Detailed 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.

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-02-08
• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-02-20
• Last Update Submitted: 2025-02-20
• Study First Posted: 2025-02-25
• Last Update Posted: 2025-02-25
• Primary Completion: 2026-03
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

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 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 affected eye 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 and pioglitazone)
• Patients already on SGLT2 inhibitor drugs (dapagliflozin, canagliflozin, or empagliflozin) before recruitment
• Patients on topical prostaglandin analogs (e.g., latanoprost, travoprost, ioprost, and tafluprost)
• Patients diagnosed with ocular surface infections until treated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Dapagliflozin	The treatment group will receive oral dapagliflozin 10 mg daily in addition to standard of care intravitreal aflibercept injections.
Treatment group	Anti-VEGF drug	The treatment group will receive oral dapagliflozin 10 mg daily in addition to standard of care intravitreal aflibercept injections.
Control group	Anti-VEGF drug	The control group will receive standard of care intravitreal aflibercept injections.

Primary Outcome Measures

Name	Time	Method
Mean central subfield thickness (CST)	Baseline, 3 months	The reduction in mean central subfield thickness (CST) from baseline will be determined using Optical Coherence Tomography (OCT) and compared between study groups.
The best-corrected visual acuity (BCVA)	Baseline, 3 months	The improvement in the best-corrected visual acuity (BCVA) from baseline will be recorded and compared between study groups.

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with persistent macular edema	3 months	The number of patients with persistent macular edema who are indicated to continue intravitreal anti-VEGF therapy beyond the initial 3 injections will be compared across study groups.
Retinal anatomical changes	Baseline, 3 months	Retinal anatomical changes such as the improvement of cystoid macular spaces and resolution of subretinal fluid will be determined on OCT.
Visual impairment patient reported outcome	Baseline, 3 months	Patient reported outcome measures for visual impairment will be reported at baseline and after receiving interventions, using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25), and compared across study groups.
Incidence of adverse events	3 months	Systemic and ocular adverse events will be recorded and compared across study groups to assess the safety profile of the interventions.
Measuring the levels of some inflammatory cytokines in the aqueous humor	Baseline, 2 months	The routinely withdrawn aqueous humor samples from patients with DME during intravitreal anti-VEGF injection will be collected and analyzed. The levels of inflammatory cytokines VEGF-A, interleukin (IL)-6, monocyte chemoattractant protein 1 (MCP-1), and tumor necrosis factor (TNF)-α, will be quantified, using multiplex protein analysis, and compared between the study groups.

Trial Locations

Locations (1)

Alexandria Main University Hospital, The Ophthalmology Department, Faculty of Medicine, Alexandria University; 🇪🇬 Alexandria, Egypt