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

NCT06845163 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-06-19

No results posted yet for this study

Summary

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

Interventions

DRUG

Dapagliflozin

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

DRUG

Anti-VEGF drug

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

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Principal Investigators

  • Amira A. Nayel, MSc · Clinical researcher and PhD student at the Faculty of Pharmacy, Alexandria University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-08
Primary Completion
2026-03-31
Completion
2026-08-31

Countries

  • Egypt

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06845163 on ClinicalTrials.gov