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

NCT06984822 | Recruiting

• 1 other identifier: BiomarkerOCT
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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).

Conditions

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

Keywords

optical coherence tomography

Outcome Measures

Primary Outcomes (8)

• Serum levels of Vascular Endothelial Growth Factor (VEGF)

  Serum levels of VEGF

  At baseline (and for group 3. naive patients also after 4 weeks)

• Serum levels of interleukin 6 (IL-6)

  Serum levels of IL-6

  At baseline (and for group 3. naive patients also after 4 weeks)

• Serum levels of interleukin 8 (IL-8)

  Serum levels of IL-8

  At baseline (and for group 3. naive patients also after 4 weeks)

• Serum levels of monocyte chemoattractant protein 1 (MCP-1)

  Serum levels of MCP-1

  At baseline (and for group 3. naive patients also after 4 weeks)

• Serum levels of angiopoietin 2 (Ang-2)

  Serum levels of Ang-2

  At baseline (and for group 3. naive patients also after 4 weeks)

• Serum levels of placental growth factor (PlGF)

  Serum levels of PIGF

  At baseline (and for group 3. naive patients also after 4 weeks)

• Serum levels of tumor necrosis factor alpha (TNF-a)

  Serum levels of TNF-a

  At baseline (and for group 3. naive patients also after 4 weeks)

• Serum levels of intercellular adhesion molecule 1 (ICAM-1)

  Serum levels of ICAM-1

  At baseline (and for group 3. naive patients also after 4 weeks)

Secondary Outcomes (4)

• Incidence of OCT-biomarker disorgani-zation of retinal inner layers (DRIL)

  At baseline and after 4 weeks

• Incidence of OCT-biomarker disruption of retinal outer layers (DROL)

  At baseline and after 4 weeks

• Incidence of OCT-biomarker hyper-reflective foci (HRF)

  At baseline and after 4 weeks

• Incidence of OCT-biomarker subretinal fluid (SRF)

  At baseline and after 4 weeks

Study Arms (3)

Anti-VEGF treated patients

EXPERIMENTAL

Patients with ongoing anti-VEGF treatment

Drug: Anti-VEGF treatment

Dexamethasone treated patients

EXPERIMENTAL

Patients with ongoing Dexamethasone implant treatment

Device: Dexamethasone implant

Patients not previously treated for DME

EXPERIMENTAL

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

Other: Treatment with intravitreal anti-VEGF OR Dexamethasone implant

Interventions

Anti-VEGF treatment DRUG

Treatment with intravitreal anti-VEGF treatment

Anti-VEGF treated patients

Dexamethasone implant DEVICE

Treatment with Dexamethasone implant

Also known as: Dexamethasone treatment

Dexamethasone treated patients

Treatment with intravitreal anti-VEGF OR Dexamethasone implant OTHER

Treatment with intravitreal anti-VEGF OR treatment with Dexamethasone implant

Also known as: Anti-VEGF OR Dexamethasone treatment

Patients not previously treated for DME

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (2)

Sahlgrenska University Hospital, Department of Ophthalmology

Mölndal, 431 80, Sweden

RECRUITING

Ögonmottagning Mölndal/SU

Mölndal, 43130, Sweden

NOT YET RECRUITING

MeSH Terms

Conditions

Vision Disorders; Diabetes Mellitus; Hyperglycemia

Interventions

Therapeutics; Dexamethasone

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Marita Grönlund, M.D. Prof

  Göteborg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imadeddin Abu Ishkheidem, M.D.

CONTACT

+46738744867; imadeddin.abu.ishkheidem@vgregion.se

Sofia Töyrä Silfverswärd, PhD

CONTACT

0761283085; sofia.toyra.silfversward@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Prospective, observational, controlled, non-randomized, monocenter study.

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 22, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 21, 2025

Record last verified: 2025-04

Locations

SE (2)