Randomized Clinical Trial to Evaluate the Effect of Dapagliflozin in Patients With Diabetic Macular Edema
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAlexandria University
About this trial
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?
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Dapagliflozin
- Anti-VEGF drug
Treatment groups
56 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov