Evaluating Dapagliflozin for Diabetic Macular Edema Treatment

Clinical Study on the Efficacy of Oral Dapagliflozin Combined With Intravitreal Injection of Anti-Vascular Endothelial Growth Factor in Patients With Diabetic Macular Edema

This study is testing if adding a diabetes pill called dapagliflozin to regular eye injections can help people with diabetic macular edema see better and reduce swelling in their eyes.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Alexandria University (other)
• Locations: 1 site (Alexandria, Alexandria Governorate)
• Trial ID: NCT06845163 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of dapagliflozin, an SGLT2 inhibitor, as an adjunct therapy to intravitreal aflibercept injections in patients with center-involved diabetic macular edema (ci-DME). The study employs a randomized, double-blind, parallel group design, comparing the combination treatment to aflibercept alone. The primary focus is on assessing the reduction of macular central subfield thickness and improvement in visual acuity among participants with type II diabetes. Participants will receive oral dapagliflozin daily alongside standard anti-VEGF therapy to determine if this combination yields better outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults with type II diabetes mellitus who are on premixed insulin and metformin and have been diagnosed with center-involved diabetic macular edema.

Not a fit: Patients with type I diabetes, those under 18 years old, or individuals with other causes of macular edema will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to improved vision and reduced retinal thickness for patients suffering from diabetic macular edema.

How similar studies have performed: While the use of SGLT2 inhibitors in diabetic macular edema is emerging, this specific combination approach with dapagliflozin and anti-VEGF therapy is relatively novel and has not been extensively tested.

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

Where this trial is running

Alexandria, Alexandria Governorate

• Alexandria Main University Hospital, The Ophthalmology Department, Faculty of Medicine, Alexandria University — Alexandria, Alexandria Governorate, Egypt (RECRUITING)

Study contacts

• Principal investigator: Amira A. Nayel, MSc — Clinical researcher and PhD student at the Faculty of Pharmacy, Alexandria University
• Study coordinator: Amira A. Nayel, Pharm.D, MSc

Conditions: Diabetic Macular Edema, Center-involved Diabetic Macular Edema, center-involved diabetic macular edema, Anti-VEGF, Aflibercept, EYLEA, Dapagliflozin, Forxiga