Anti-VEGF treatmentDexamethasone implantTreatment with intravitreal anti-VEGF OR Dexamethasone implant
Anti-VEGF treatment: Treatment with intravitreal anti-VEGF treatment
Dexamethasone implant: Treatment with Dexamethasone implant
Treatment with intravitreal anti-VEGF OR Dexamethasone implant: Treatment with intravitreal anti-VEGF OR treatment with Dexamethasone implant
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)
Serum levels of Vascular Endothelial Growth Factor (VEGF) — At baseline (and for group 3. naive patients also after 4 weeks) Serum levels of VEGF
Serum levels of interleukin 6 (IL-6) — At baseline (and for group 3. naive patients also after 4 weeks) Serum levels of IL-6
Serum levels of interleukin 8 (IL-8) — At baseline (and for group 3. naive patients also after 4 weeks) Serum levels of IL-8
Serum levels of monocyte chemoattractant protein 1 (MCP-1) — At baseline (and for group 3. naive patients also after 4 weeks) Serum levels of MCP-1
Serum levels of angiopoietin 2 (Ang-2) — At baseline (and for group 3. naive patients also after 4 weeks) Serum levels of Ang-2
Serum levels of placental growth factor (PlGF) — At baseline (and for group 3. naive patients also after 4 weeks) Serum levels of PIGF
Serum levels of tumor necrosis factor alpha (TNF-a) — At baseline (and for group 3. naive patients also after 4 weeks) Serum levels of TNF-a
Serum levels of intercellular adhesion molecule 1 (ICAM-1) — At baseline (and for group 3. naive patients also after 4 weeks) Serum levels of ICAM-1
Trial sites (2)
Facility
City
Region
Status
Sahlgrenska University Hospital, Department of Ophthalmology
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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