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

Sponsor
Alexandria University
Study ID
NCT06845163
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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?

Key Dates

Start date
Feb 8, 2025
Status verified
Feb 2025
Primary completion
Mar 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group
    The treatment group will receive oral dapagliflozin 10 mg daily in addition to standard of care intravitreal aflibercept injections.
  • Active Comparator: Control group
    The control group will receive standard of care intravitreal aflibercept injections.

Primary Outcome Measure

Mean central subfield thickness (CST) [ Time Frame: Baseline, 3 months ]

Central Contacts

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