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

NCT06845163 | Recruiting Phase 2

• 1 other identifier: 0202071
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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?

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

Outcome Measures

Primary Outcomes (2)

• Mean central subfield thickness (CST)

  The reduction in mean central subfield thickness (CST) from baseline will be determined using Optical Coherence Tomography (OCT) and compared between study groups.

  Baseline, 3 months

• The best-corrected visual acuity (BCVA)

  The improvement in the best-corrected visual acuity (BCVA) from baseline will be recorded and compared between study groups.

  Baseline, 3 months

Secondary Outcomes (5)

• Percentage of patients with persistent macular edema

  3 months

• Retinal anatomical changes

  Baseline, 3 months

• Visual impairment patient reported outcome

  Baseline, 3 months

• Incidence of adverse events

  3 months

• Measuring the levels of some inflammatory cytokines in the aqueous humor

  Baseline, 2 months

Study Arms (2)

Treatment group

EXPERIMENTAL

The treatment group will receive oral dapagliflozin 10 mg daily in addition to standard of care intravitreal aflibercept injections.

Drug: Dapagliflozin; Drug: Anti-VEGF drug

Control group

ACTIVE COMPARATOR

The control group will receive standard of care intravitreal aflibercept injections.

Drug: Anti-VEGF drug

Interventions

Dapagliflozin DRUG

Dapagliflozin 10 mg will be given orally once daily for three months.

Also known as: Forxiga 10 mg

Treatment group

Anti-VEGF drug DRUG

Aflibercept 2 mg (0.05 ml) will be administered by intravitreal injection every month for three consecutive months.

Also known as: Aflibercept (Eylea)

Control group; Treatment group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type II diabetes mellitus patients, treated with premixed insulin and metformin, and diagnosed with center-involved diabetic macular edema (CiDME)
• Presence of retinal thickening involving the center of the fovea (CiDME) in the study eye on Optical Coherence Tomography (OCT) Heidelberg Spectralis; If both eyes are eligible, the eye with the greater central subfield thickness on OCT is selected as the study eye.
• Decreased visual acuity primarily attributable to DME
• Clear ocular media and pupillary dilation for adequate retinal imaging
• Ability to understand the study procedures and willingness to provide written informed consent

You may not qualify if:

• Patients below 18 years old and patients above 85 years old
• Patients with type I diabetes mellitus (Insulin dependent diabetes mellitus IDDM)
• Pregnant women and lactating women diagnosed with diabetes or intending to become pregnant in the next 12 months
• Patients who had myocardial infarction within 3 months prior to screening
• Patients who had transient ischemic attack (TIA), ischemic or hemorrhagic stroke within 3 months prior to screening
• Patients with poorly controlled diabetes mellitus, defined as patients having glycosylated hemoglobin (HbA1c) level of ≥12% at screening or patients who were hospitalized for diabetic ketoacidosis or hyperosmolar coma within 4 months prior to screening
• Patients with estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 at screening
• Patients with severe hepatic impairment of Child-Turcotte-Pugh class C at screening
• Patients treated with antidiabetic drugs thiazolidinediones (TZD) (rosiglitazone and pioglitazone) prior to screening
• Patients who were receiving SGLT2 inhibitors (e.g., dapagliflozin, canagliflozin, or empagliflozin) within 3 months prior to screening
• Known allergy or hypersensitivity to any component of the study drugs
• Current or previous participation in another clinical study involving the systemic or ocular administration of an investigational drug or device within 6 months of screening
• Macular edema caused by other conditions than diabetic macular edema or coexisting with DME such as retinal vein occlusion, choroidal neovascularization (CNV), or uveitic cystoid macular edema
• History of postoperative cystoid macular edema (Irvine-Gass syndrome)
• Cataract extraction within 3 months prior to screening

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

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

Alexandria, Alexandria Governorate, Egypt

RECRUITING

MeSH Terms

Interventions

dapagliflozin; aflibercept

Study Officials

• Amira A. Nayel, MSc

  Clinical researcher and PhD student at the Faculty of Pharmacy, Alexandria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amira A. Nayel, Pharm.D, MSc

CONTACT

+201022715779; gs-amira.nayel@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 25, 2025
• Study Start: February 8, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)