RecruitingNot ApplicableNCT06984822

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

Evaluation of Serum and Ocular Coherence Tomography Biomarkers in Patients With Diabetic Macular Edema Treated With Anti-VEGF or Dexamethasone Implant


Sponsor

Vastra Gotaland Region

Enrollment

150 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria7

  • 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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Interventions

DRUGAnti-VEGF treatment

Treatment with intravitreal anti-VEGF treatment

DEVICEDexamethasone implant

Treatment with Dexamethasone implant

OTHERTreatment with intravitreal anti-VEGF OR Dexamethasone implant

Treatment with intravitreal anti-VEGF OR treatment with Dexamethasone implant


Locations(2)

Sahlgrenska University Hospital, Department of Ophthalmology

Mölndal, Sweden

Ögonmottagning Mölndal/SU

Mölndal, Sweden

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NCT06984822


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