Actively Recruiting
Evaluation of Serum and Ocular Coherence Tomography Biomarkers in Patients With Diabetic Macular Edema Treated With Anti-VEGF or Dexamethasone Implant
Led by Vastra Gotaland Region · Updated on 2025-11-21
150
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to investigate the relationship between blood serum biomarkers and how patients with diabetic macular edema (DME) respond to treatments with anti-VEGF or dexamethasone implants. The study compares these treatments to a group of patients who have not previously received treatment for DME. Researchers will also assess eye imaging markers using OCT scans to better understand this condition. Participants will be divided into three groups: those receiving anti-VEGF treatment, those receiving dexamethasone implants, and those who are treatment-naive. Blood samples will be taken at the start for all groups, and again after four weeks for the untreated group. OCT scans of the retina and choroid will be performed at baseline and after four weeks to evaluate specific imaging markers related to DME. During the study, participants will undergo blood tests to measure levels of several biomarkers including VEGF, IL-6, IL-8, MCP-1, Ang-2, PlGF, TNF-a, and ICAM-1. OCT scans will be analyzed for retinal layer disruptions and fluid presence. Researchers will classify participants based on their response to treatment and monitor changes over the four-week period. The total participation time varies based on group and treatment status.
CONDITIONS
Brief Title
Evaluation of Serum- and OCT Biomarkers in Patients With DME Treated With Anti-VEGF or Dexamethasone Implant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Type I or type II diabetes mellitus
- Diabetic macular edema involving the center of the fovea with central foveal thickness more than 280 microns
- Presence of intraretinal cysts
- Age 18 years or older
You will not qualify if you...
- History of any other macular disease
- Previous treatment with dexamethasone implants in the last six months for patients in the anti-VEGF group
- Previous treatment with anti-VEGF in the last two months for patients in the dexamethasone implant group
- Prior vitreoretinal surgery
- Previous laser treatment of the macula
- Previous panretinal photocoagulation
- Ocular surgery in the previous 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive treatment with either intravitreal anti-VEGF or Dexamethasone implant, or are observed if treatment-naive. Blood samples and OCT scans are collected at baseline and after 4 weeks of treatment to assess biomarkers and retinal changes.
2 visits (in-person) at baseline and 4 weeks
Trial Site Locations
Total: 2 locations
1
Sahlgrenska University Hospital, Department of Ophthalmology
Mölndal, Sweden, 431 80
Actively Recruiting
2
Ögonmottagning Mölndal/SU
Mölndal, Sweden, 43130
Not Yet Recruiting
Research Team
I
Imadeddin Abu Ishkheidem, M.D.
S
Sofia Töyrä Silfverswärd, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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