NCT06984822

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Macular Edema
• Visual Impairment
• Diabetes Mellitus
• Hyperglycaemia (Diabetic)
• Oxidative Stress
• Vascular Endothelial Growth Factor
• VEGF

Interventions

Type	Name	Description
DRUG	Anti-VEGF treatment	Treatment with intravitreal anti-VEGF treatment
DEVICE	Dexamethasone implant	Treatment with Dexamethasone implant
OTHER	Treatment with intravitreal anti-VEGF OR Dexamethasone implant	Treatment with intravitreal anti-VEGF OR treatment with Dexamethasone implant

Timeline

• Start date: 2025-08-01
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2025-05-22
• Last updated: 2025-11-21

Locations

2 sites across 1 country: Sweden