Clinical trial NCT06845163: Randomized Clinical Trial to Evaluate the Effect of Dapagliflozin in Patients With Diabetic Macular Edema
Official title: Clinical Study on the Efficacy of Oral Dapagliflozin Combined With Intravitreal Injection of Anti-Vascular Endothelial Growth Factor in Patients With Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diabetic Macular Edema
Center-involved Diabetic Macular Edema
Keywords: Diabetic Macular Edema
center-involved diabetic macular edema
Anti-VEGF
Aflibercept
EYLEA
Dapagliflozin
Forxiga
SGLT2 inhibitor
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean central subfield thickness (CST)
timeFrame: Baseline, 3 months
measure: The best-corrected visual acuity (BCVA)
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Percentage of patients with persistent macular edema
timeFrame: 3 months
measure: Retinal anatomical changes
timeFrame: Baseline, 3 months
measure: Visual impairment patient reported outcome
timeFrame: Baseline, 3 months
measure: Incidence of adverse events
timeFrame: 3 months
measure: Measuring the levels of some inflammatory cytokines in the aqueous humor
timeFrame: Baseline, 2 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Main University Hospital, The Ophthalmology Department, Faculty of Medicine, Alexandria University
Study officials:
affiliation: Clinical researcher and PhD student at the Faculty of Pharmacy, Alexandria University
name: Amira A. Nayel, MSc
role: PRINCIPAL_INVESTIGATOR
References: