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Recruiting NCT06984822

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

No phase Interventional Diabetic Macular Edema Visual Impairment Diabetes Mellitus Hyperglycaemia (Diabetic)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anti-VEGF treatment, Dexamethasone implant, Treatment with intravitreal anti-VEGF OR Dexamethasone implant.
Who it may be relevant to
Registry conditions: Diabetic Macular Edema, Visual Impairment, Diabetes Mellitus, Hyperglycaemia (Diabetic). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • 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

Primary outcome measures

  • Serum levels of Vascular Endothelial Growth Factor (VEGF) [Time frame: At baseline (and for group 3. naive patients also after 4 weeks)]
  • Serum levels of interleukin 6 (IL-6) [Time frame: At baseline (and for group 3. naive patients also after 4 weeks)]
  • Serum levels of interleukin 8 (IL-8) [Time frame: At baseline (and for group 3. naive patients also after 4 weeks)]
  • Serum levels of monocyte chemoattractant protein 1 (MCP-1) [Time frame: At baseline (and for group 3. naive patients also after 4 weeks)]
  • Serum levels of angiopoietin 2 (Ang-2) [Time frame: At baseline (and for group 3. naive patients also after 4 weeks)]
  • Serum levels of placental growth factor (PlGF) [Time frame: At baseline (and for group 3. naive patients also after 4 weeks)]
  • Serum levels of tumor necrosis factor alpha (TNF-a) [Time frame: At baseline (and for group 3. naive patients also after 4 weeks)]
  • Serum levels of intercellular adhesion molecule 1 (ICAM-1) [Time frame: At baseline (and for group 3. naive patients also after 4 weeks)]
Secondary outcome measures (4)
  • Incidence of OCT-biomarker disorgani-zation of retinal inner layers (DRIL) [Time frame: At baseline and after 4 weeks]
  • Incidence of OCT-biomarker disruption of retinal outer layers (DROL) [Time frame: At baseline and after 4 weeks]
  • Incidence of OCT-biomarker hyper-reflective foci (HRF) [Time frame: At baseline and after 4 weeks]
  • Incidence of OCT-biomarker subretinal fluid (SRF) [Time frame: At baseline and after 4 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Sweden · 2 centers
  • Sahlgrenska University Hospital, Department of Ophthalmology — Mölndal
  • Ögonmottagning Mölndal/SU — Mölndal

Identifiers

NCT: NCT06984822 · BiomarkerOCT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗