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New treatment option for Diabetic Macular Edema
Official title Randomized Clinical Trial to Evaluate the Effect of Dapagliflozin in Patients With Diabetic Macular Edema
ClinicalTrials.gov ID: NCT06845163
What this study is testing
What is Dapagliflozin?
Dapagliflozin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for diabetic macular edema.
Also referred to as Forxiga 10 mg.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join 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...
- 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
You likely can't join 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...
See the full eligibility 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Alexandria, Alexandria Governorate, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alexandria, Alexandria Governorate, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.