Evaluation of Serum- and OCT Biomarkers in Patients With DME Treated With Anti-VEGF or Dexamethasone Implant

Evaluation of Serum and Ocular Coherence Tomography Biomarkers in Patients With Diabetic Macular Edema Treated With Anti-VEGF or Dexamethasone Implant

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.

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.