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

Vastra Gotaland Region

Status: Enrolling

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

Treatments: Device: Dexamethasone implant; Other: Treatment with intravitreal anti-VEGF OR Dexamethasone implant; Drug: Anti-VEGF treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06984822

BiomarkerOCT

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Anti-VEGF treated patients

Experimental group

Description:

Patients with ongoing anti-VEGF treatment

Treatment:

Drug: Anti-VEGF treatment

Dexamethasone treated patients

Experimental group

Description:

Patients with ongoing Dexamethasone implant treatment

Treatment:

Device: Dexamethasone implant

Patients not previously treated for DME

Experimental group

Description:

Treatment-naive patients (neither anti-VEGF treatment nor Dexamethasone implant treatment)

Treatment:

Other: Treatment with intravitreal anti-VEGF OR Dexamethasone implant