Clinical trial NCT06984822: Evaluation of Serum- and OCT Biomarkers in Patients With DME Treated With Anti-VEGF or Dexamethasone Implant
Official title: Evaluation of Serum and Ocular Coherence Tomography Biomarkers in Patients With Diabetic Macular Edema Treated With Anti-VEGF or Dexamethasone Implant
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetic Macular Edema
Visual Impairment
Diabetes Mellitus
Hyperglycaemia (Diabetic)
Oxidative Stress
Vascular Endothelial Growth Factor
VEGF
Keywords: optical coherence tomography
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2025-05-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, observational, controlled, non-randomized, monocenter study.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serum levels of Vascular Endothelial Growth Factor (VEGF)
timeFrame: At baseline (and for group 3. naive patients also after 4 weeks)
measure: Serum levels of interleukin 6 (IL-6)
timeFrame: At baseline (and for group 3. naive patients also after 4 weeks)
measure: Serum levels of interleukin 8 (IL-8)
timeFrame: At baseline (and for group 3. naive patients also after 4 weeks)
measure: Serum levels of monocyte chemoattractant protein 1 (MCP-1)
timeFrame: At baseline (and for group 3. naive patients also after 4 weeks)
measure: Serum levels of angiopoietin 2 (Ang-2)
timeFrame: At baseline (and for group 3. naive patients also after 4 weeks)
measure: Serum levels of placental growth factor (PlGF)
timeFrame: At baseline (and for group 3. naive patients also after 4 weeks)
measure: Serum levels of tumor necrosis factor alpha (TNF-a)
timeFrame: At baseline (and for group 3. naive patients also after 4 weeks)
measure: Serum levels of intercellular adhesion molecule 1 (ICAM-1)
timeFrame: At baseline (and for group 3. naive patients also after 4 weeks)
Secondary outcomes:
measure: Incidence of OCT-biomarker disorgani-zation of retinal inner layers (DRIL)
timeFrame: At baseline and after 4 weeks
measure: Incidence of OCT-biomarker disruption of retinal outer layers (DROL)
timeFrame: At baseline and after 4 weeks
measure: Incidence of OCT-biomarker hyper-reflective foci (HRF)
timeFrame: At baseline and after 4 weeks
measure: Incidence of OCT-biomarker subretinal fluid (SRF)
timeFrame: At baseline and after 4 weeks
Other outcomes:
Locations:
city: Mölndal
country: Sweden
facility: Ögonmottagning Mölndal/SU
Study officials:
affiliation: Göteborg University
name: Marita Grönlund, M.D. Prof
role: PRINCIPAL_INVESTIGATOR
References: