NCT06845163CompletedPhase 2
Randomized Clinical Trial to Evaluate the Effect of Dapagliflozin in Patients With Diabetic Macular Edema
Clinical Study on the Efficacy of Oral Dapagliflozin Combined With Intravitreal Injection of Anti-Vascular Endothelial Growth Factor in Patients With Diabetic Macular Edema
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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?
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 56 (actual)
- First submitted
- 20 Feb 2025
- Start date
- 8 Feb 2025
- Primary completion date
- 14 Jul 2026
- Lead sponsor
- Alexandria University
- Diseases
- Diabetic eye disease
- NCT number
- NCT06845163
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 56
- From 8 Feb 2025 to the primary completion date, 14 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Alexandria Main University Hospital, The Ophthalmology Department, Faculty of Medicine, Alexandria University Coordinator of this site? Confirm its status | Alexandria | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.