Status:
RECRUITING
Evaluation of Serum- and OCT Biomarkers in Patients With DME Treated With Anti-VEGF or Dexamethasone Implant
Lead Sponsor:
Vastra Gotaland Region
Conditions:
Diabetic Macular Edema
Visual Impairment
Eligibility:
All Genders
18+ years
Phase:
NA
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,...
Detailed Description
This prospective, observational, controlled, non-randomized, monocenter study will include patients with DME at the Sahlgrenska University Hospital in Gothenburg, Sweden undergoing treatment with eith...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06984822
Start Date
August 1 2025
End Date
December 31 2028
Last Update
November 21 2025
Active Locations (2)
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1
Sahlgrenska University Hospital, Department of Ophthalmology
Mölndal, Sweden, 431 80
2
Ögonmottagning Mölndal/SU
Mölndal, Sweden, 43130