An interventional study of Anti-VEGF treatment and Dexamethasone implant in Diabetic Macular Edema, Visual Impairment and Diabetes Mellitus, sponsored by Vastra Gotaland Region. Recruiting at 2 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by Vastra Gotaland Region · Not applicable, Interventional, and Prevention
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).
This prospective, observational, controlled, non-randomized, monocenter study will include patients with DME at the Sahlgrenska University Hospital in Gothenburg, Sweden undergoing treatment with either anti-VEGF or dexamethasone implant, or those being previously untreated.
Patients will be segregated into three primary cohorts: 1. patients currently treated with anti-VEGF, 2. patients currently treated with dexamethasone implants, and 3. patients not previously treated for DME (naive patients).
Patients blood will be analyzed for serum biomarkers known to correlate with DME: VEGF, IL-6, IL-8, MCP-1, Ang-2, PlGF, TNF-a, and ICAM-1. Blood will be drawn at study entry/baseline for all three groups, and for group 3. naive patients, blood will also be drawn after 4 weeks of treatment.
OCT scans will be performed at study entry/baseline and after 4 weeks of treatment for qualitative and quantitative assessment of the retina and choroid and scans will be analyzed for the following markers: DRIL, DROL, HRF, and subretinal fluid (SRF).
Based on the response to treatment, investigators plan to further divide patients into two subcategories: responders vs non-responders.
The investigators intent is to scrutinize any correlation between circulating serum biomarkers and imaging biomarkers.
360 studies on the registry are indexed under Vision Disorders; 84 are open to participants now.
This study's planned enrollment of 150 is above the median of 78 across 244 interventional studies indexed under Vision Disorders.
Browse Vision Disorders studies →Vastra Gotaland Region is the lead sponsor of 275 studies on the registry; 109 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with ongoing anti-VEGF treatment
Drug: Anti-VEGF treatment
Patients with ongoing Dexamethasone implant treatment
Device: Dexamethasone implant
Treatment-naive patients (neither anti-VEGF treatment nor Dexamethasone implant treatment)
Other: Treatment with intravitreal anti-VEGF OR Dexamethasone implant
Treatment with intravitreal anti-VEGF treatment
Treatment with Dexamethasone implant
Also known as: Dexamethasone treatment
Treatment with intravitreal anti-VEGF OR treatment with Dexamethasone implant
Also known as: Anti-VEGF OR Dexamethasone treatment
Serum levels of Vascular Endothelial Growth Factor (VEGF)
Serum levels of VEGF
Time frame: At baseline (and for group 3. naive patients also after 4 weeks)
Serum levels of interleukin 6 (IL-6)
Serum levels of IL-6
Time frame: At baseline (and for group 3. naive patients also after 4 weeks)
Serum levels of interleukin 8 (IL-8)
Serum levels of IL-8
Time frame: At baseline (and for group 3. naive patients also after 4 weeks)
Serum levels of monocyte chemoattractant protein 1 (MCP-1)
Serum levels of MCP-1
Time frame: At baseline (and for group 3. naive patients also after 4 weeks)
Serum levels of angiopoietin 2 (Ang-2)
Serum levels of Ang-2
Time frame: At baseline (and for group 3. naive patients also after 4 weeks)
Serum levels of placental growth factor (PlGF)
Serum levels of PIGF
Time frame: At baseline (and for group 3. naive patients also after 4 weeks)
Serum levels of tumor necrosis factor alpha (TNF-a)
Serum levels of TNF-a
Time frame: At baseline (and for group 3. naive patients also after 4 weeks)
Serum levels of intercellular adhesion molecule 1 (ICAM-1)
Serum levels of ICAM-1
Time frame: At baseline (and for group 3. naive patients also after 4 weeks)
Incidence of OCT-biomarker disorgani-zation of retinal inner layers (DRIL)
Differences in frequencies for DRIL
Time frame: At baseline and after 4 weeks
Incidence of OCT-biomarker disruption of retinal outer layers (DROL)
Differences in frequencies for OCT-biomarker DROL
Time frame: At baseline and after 4 weeks
Incidence of OCT-biomarker hyper-reflective foci (HRF)
Differences in frequencies for OCT-biomarker HRF
Time frame: At baseline and after 4 weeks
Incidence of OCT-biomarker subretinal fluid (SRF)
Differences in frequencies for OCT-biomarker SRF
Time frame: At baseline and after 4 weeks
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