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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
150
Treatment with intravitreal anti-VEGF treatment
Treatment with Dexamethasone implant
Treatment with intravitreal anti-VEGF OR treatment with Dexamethasone implant
Sahlgrenska University Hospital, Department of Ophthalmology
Mölndal, Sweden
RECRUITINGÖgonmottagning Mölndal/SU
Mölndal, Sweden
NOT_YET_RECRUITINGSerum 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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