Actively Recruiting
Randomized Clinical Trial to Evaluate the Effect of Dapagliflozin in Patients With Diabetic Macular Edema
Led by Alexandria University · Updated on 2025-06-19
56
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
Randomized Clinical Trial to Evaluate the Effect of Dapagliflozin in Patients With Diabetic Macular Edema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Type II diabetes mellitus patients treated with premixed insulin and metformin who have center-involved diabetic macular edema (CiDME)
- Retinal thickening involving the center of the fovea in the study eye confirmed by Optical Coherence Tomography (OCT)
- Decreased visual acuity mainly due to diabetic macular edema
- Clear ocular media and ability to dilate pupils for retinal imaging
- Ability to understand study procedures and provide written informed consent
You will not qualify if you...
- Younger than 18 years or older than 85 years
- Diagnosis of type I diabetes mellitus
- Pregnant or breastfeeding women or those planning pregnancy within 12 months
- Heart attack within 3 months before screening
- Stroke or transient ischemic attack within 3 months before screening
- Poorly controlled diabetes with HbA1c 12% or higher or hospitalization for diabetic ketoacidosis or hyperosmolar coma within 4 months
- Estimated glomerular filtration rate less than 30 mL/min/1.73 m2
- Severe liver impairment (Child-Turcotte-Pugh class C)
- Prior treatment with thiazolidinediones (rosiglitazone or pioglitazone)
- Use of SGLT2 inhibitors within 3 months before screening
- Allergy or sensitivity to study drugs
- Participation in another investigational drug or device study within 6 months
- Macular edema caused by other conditions or coexisting with diabetic macular edema
- History of postoperative cystoid macular edema
- Cataract surgery within 3 months before screening
- Previous macular laser treatment
- Panretinal photocoagulation laser treatment within 6 months
- Intravitreal anti-VEGF or corticosteroid treatment within 6 months
- Use of corticosteroid or non-steroidal anti-inflammatory eye drops within 1 month
- Use of topical prostaglandin analogs at screening
- History of vitrectomy or scleral buckling
- Significant vitreomacular traction or thick epiretinal membrane causing traction
- Tractional retinal detachment involving macula requiring vitrectomy
- Other macular pathologies such as scars or holes
- Presence of rubeosis iridis
- Signs of hypertensive retinopathy
- Presence of glaucoma
- Aphakia
- YAG laser capsulotomy within 3 months
- Untreated ocular surface infections
- Non-study eye receiving simultaneous intravitreal anti-VEGF treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Alexandria Main University Hospital, The Ophthalmology Department, Faculty of Medicine, Alexandria University
Alexandria, Alexandria Governorate, Egypt
Actively Recruiting
Research Team
A
Amira A. Nayel, Pharm.D, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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