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

Exclusion Criteria31

• 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
• 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
• The non-study eye receiving simultaneous intravitreal anti-VEGF treatment with the study eye