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

Study acronym: DAPA-DME
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 19, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Eligibility criteria expanded, about 339 wordsv2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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?
Trial Details
NCT Number NCT06845163
Lead Sponsor Alexandria University
Conditions
(from sponsor)
Diabetic Macular Edema, Center-involved Diabetic Macular Edema
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov