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

ConditionsDiabetic Macular Edema Visual Impairment Diabetes Mellitus Hyperglycaemia (Diabetic)Oxidative Stress Vascular Endothelial Growth Factor VEGF

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorVastra Gotaland Region

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

Anti-VEGF treatment
Dexamethasone implant
Treatment with intravitreal anti-VEGF OR Dexamethasone implant

Treatment groups

150 Participants

are divided into 3 treatment groups

Locations

Ögonmottagning Mölndal/SU43130, Mölndal Sweden

Sahlgrenska University Hospital, Department of Ophthalmology431 80, Mölndal Sweden

Sponsors and collaborators

Vastra Gotaland Region

Lead sponsor

Source ClinicalTrials.gov