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

ConditionsDiabetic Macular EdemaVisual ImpairmentDiabetes MellitusHyperglycaemia (Diabetic)Oxidative StressVascular Endothelial Growth FactorVEGF
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVastra Gotaland Region

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anti-VEGF treatment

    Drug

    Treatment with intravitreal anti-VEGF treatment

  • Dexamethasone implant

    Device

    Treatment with Dexamethasone implant

  • Treatment with intravitreal anti-VEGF OR Dexamethasone implant

    Other intervention

    Treatment with intravitreal anti-VEGF OR treatment with Dexamethasone implant

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Anti-VEGF treated patientsExperimental treatment 1 intervention
Group B: Dexamethasone treated patientsExperimental treatment 1 intervention
Group C: Patients not previously treated for DMEExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Serum levels of Vascular Endothelial Growth Factor (VEGF)

Serum levels of VEGF

Time frame
At baseline (and for group 3. naive patients also after 4 weeks)
2

Serum levels of interleukin 6 (IL-6)

Serum levels of IL-6

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

Serum levels of interleukin 8 (IL-8)

Serum levels of IL-8

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

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

Serum levels of MCP-1

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

Secondary outcomes

1

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

Differences in frequencies for DRIL

Time frame
At baseline and after 4 weeks
2

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

Differences in frequencies for OCT-biomarker DROL

Time frame
At baseline and after 4 weeks
3

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

Differences in frequencies for OCT-biomarker HRF

Time frame
At baseline and after 4 weeks
4

Incidence of OCT-biomarker subretinal fluid (SRF)

Differences in frequencies for OCT-biomarker SRF

Time frame
At baseline and after 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vastra Gotaland Region

Lead sponsor

Source ClinicalTrials.gov
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