NCT06845163 Randomized Clinical Trial to Evaluate the Effect of Dapagliflozin in Patients With Diabetic Macular Edema

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 56 participants in total. It began in 2025-02-08 with a primary completion date of 2026-03.

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?

Eligibility Criteria

Inclusion criteria: * 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 Study participant exclusion criteria: * 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 Study eye exclusion criteria: * 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 * Patients who had previous macular laser treatment * Patients who had peripheral panretinal photocoagulation laser (PRP) treatment within 6 months prior to screening * Patients who have been treated with intravitreal anti-VEGF or intravitreal corticosteroids within 6 months prior to screening * The use of corticosteroids or non-steroidal anti-inflammatory eye drops within 1 month prior to screening * Patients on topical prostaglandin analogs (e.g., latanoprost, travoprost, ioprost, or tafluprost) at screening * History of vitrectomy or scleral buckling * Presence of diffuse vitreomacular traction or thick epiretinal membrane on OCT causing significant traction * Presence of tractional retinal detachment involving the macula and requiring vitrectomy * Presence of other associated macular pathology (e.g., macular scars or macular holes) on OCT * Presence of rubeosis iridis * Signs of hypertensive retinopathy (arterioral spasm or silver wiring of blood vessels) * Presence of glaucoma * Aphakia * Yttrium aluminum garnet (YAG) laser capsulotomy within 3 months prior to screening * Patients diagnosed with ocular surface infections until treated prior to receiving the intravitreal injections Non-study eye exclusion criteria: • The non-study eye receiving simultaneous intravitreal anti-VEGF treatment with the study eye

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