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Recruiting NCT06984822

Evaluation of Serum- and OCT Biomarkers in Patients With DME Treated With Anti-VEGF or Dexamethasone Implant

Trial Parameters

Condition Diabetic Macular Edema
Sponsor Vastra Gotaland Region
Study Type INTERVENTIONAL
Phase N/A
Enrollment 150
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-08-01
Completion 2028-12-31
Interventions
Anti-VEGF treatmentDexamethasone implantTreatment with intravitreal anti-VEGF OR Dexamethasone implant

Brief Summary

This study aims to investigate the association between serum biomarkers and clinical response to anti-VEGF or dexamethasone implant by assessing OCT-biomarkers in patients with diabetic macular edema, DME, and to compare these with a group of naive patients (those not previously treated for DME).

Eligibility Criteria

Inclusion Criteria: * Type I or type II DM. * DME involving the center of the fovea with CFT more than 280 microns and the presence of intraretinal cysts. Exclusion Criteria: * Prior history of any other macular disease. * Previous treatment with dexamethasone implants in the last six months for those in the anti-VEGF group. * Previous treatment with anti-VEGF in the last two months for those in the dexamethasone implant group. * Prior vitreoretinal surgery. * Previous laser treatment of the macula. * Previous panretinal photocoagulation. * Ocular surgery in the previous 3 months.

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