Diabetes Mellitus, Diabetic Macular Edema, Hyperglycaemia (Diabetic), Oxidative Stress, Vascular Endothelial Growth Factor, VEGF, Visual Impairment
Conditions
Keywords
optical coherence tomography
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, DME, and to compare these with a group of naive patients (those not previously treated for DME).
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 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.
Interventions
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
Sponsors
Vastra Gotaland Region
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Prospective, observational, controlled, non-randomized, monocenter study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum levels of intercellular adhesion molecule 1 (ICAM-1) | At baseline (and for group 3. naive patients also after 4 weeks) | Serum levels of ICAM-1 |
| Serum levels of monocyte chemoattractant protein 1 (MCP-1) | At baseline (and for group 3. naive patients also after 4 weeks) | Serum levels of MCP-1 |
| Serum levels of angiopoietin 2 (Ang-2) | At baseline (and for group 3. naive patients also after 4 weeks) | Serum levels of Ang-2 |
| Serum levels of placental growth factor (PlGF) | At baseline (and for group 3. naive patients also after 4 weeks) | Serum levels of PIGF |
| Serum levels of tumor necrosis factor alpha (TNF-a) | At baseline (and for group 3. naive patients also after 4 weeks) | Serum levels of TNF-a |
| Serum levels of Vascular Endothelial Growth Factor (VEGF) | At baseline (and for group 3. naive patients also after 4 weeks) | Serum levels of VEGF |
| Serum levels of interleukin 6 (IL-6) | At baseline (and for group 3. naive patients also after 4 weeks) | Serum levels of IL-6 |
| Serum levels of interleukin 8 (IL-8) | At baseline (and for group 3. naive patients also after 4 weeks) | Serum levels of IL-8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of OCT-biomarker disruption of retinal outer layers (DROL) | At baseline and after 4 weeks | Differences in frequencies for OCT-biomarker DROL |
| Incidence of OCT-biomarker hyper-reflective foci (HRF) | At baseline and after 4 weeks | Differences in frequencies for OCT-biomarker HRF |
| Incidence of OCT-biomarker subretinal fluid (SRF) | At baseline and after 4 weeks | Differences in frequencies for OCT-biomarker SRF |
| Incidence of OCT-biomarker disorgani-zation of retinal inner layers (DRIL) | At baseline and after 4 weeks | Differences in frequencies for DRIL |
Countries
Sweden
Contacts
Primary ContactImadeddin Abu Ishkheidem, M.D.
Backup ContactSofia Töyrä Silfverswärd, PhD
Outcome results
None listed