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Randomized Clinical Trial to Evaluate the Effect of Dapagliflozin in Patients With Diabetic Macular Edema

ConditionsDiabetic Macular EdemaCenter-involved 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Dapagliflozin

    Drug

    Dapagliflozin 10 mg will be given orally once daily for three months.

  • Anti-VEGF drug

    Drug

    Aflibercept 2 mg (0.05 ml) will be administered by intravitreal injection every month for three consecutive months.

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Treatment groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean central subfield thickness (CST)

The reduction in mean central subfield thickness (CST) from baseline will be determined using Optical Coherence Tomography (OCT) and compared between study groups.

Time frame
Baseline, 3 months
2

The best-corrected visual acuity (BCVA)

The improvement in the best-corrected visual acuity (BCVA) from baseline will be recorded and compared between study groups.

Time frame
Baseline, 3 months

Secondary outcomes

1

Percentage of patients with persistent macular edema

The number of patients with persistent macular edema who are indicated to continue intravitreal anti-VEGF therapy beyond the initial 3 injections will be compared across study groups.

Time frame
3 months
2

Retinal anatomical changes

Retinal anatomical changes such as the improvement of cystoid macular spaces and resolution of subretinal fluid will be determined on OCT.

Time frame
Baseline, 3 months
3

Visual impairment patient reported outcome

Patient reported outcome measures for visual impairment will be reported at baseline and after receiving interventions, using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25), and compared across study groups.

Time frame
Baseline, 3 months
4

Incidence of adverse events

Systemic and ocular adverse events will be recorded and compared across study groups to assess the safety profile of the interventions.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexandria University

Lead sponsor

Source ClinicalTrials.gov
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