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

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Препарат Anti-VEGF treatment
  Treatment with intravitreal anti-VEGF treatment
• Устройство Dexamethasone implant
  Treatment with Dexamethasone implant
• Другое Treatment with intravitreal anti-VEGF OR Dexamethasone implant
  Treatment with intravitreal anti-VEGF OR treatment with Dexamethasone implant

Первичные конечные точки

• Serum levels of Vascular Endothelial Growth Factor (VEGF) [Срок оценки: At baseline (and for group 3. naive patients also after 4 weeks)]
• Serum levels of interleukin 6 (IL-6) [Срок оценки: At baseline (and for group 3. naive patients also after 4 weeks)]
• Serum levels of interleukin 8 (IL-8) [Срок оценки: At baseline (and for group 3. naive patients also after 4 weeks)]
• Serum levels of monocyte chemoattractant protein 1 (MCP-1) [Срок оценки: At baseline (and for group 3. naive patients also after 4 weeks)]
• Serum levels of angiopoietin 2 (Ang-2) [Срок оценки: At baseline (and for group 3. naive patients also after 4 weeks)]
• Serum levels of placental growth factor (PlGF) [Срок оценки: At baseline (and for group 3. naive patients also after 4 weeks)]
• Serum levels of tumor necrosis factor alpha (TNF-a) [Срок оценки: At baseline (and for group 3. naive patients also after 4 weeks)]
• Serum levels of intercellular adhesion molecule 1 (ICAM-1) [Срок оценки: At baseline (and for group 3. naive patients also after 4 weeks)]

Вторичные конечные точки (4)

• Incidence of OCT-biomarker disorgani-zation of retinal inner layers (DRIL) [Срок оценки: At baseline and after 4 weeks]
• Incidence of OCT-biomarker disruption of retinal outer layers (DROL) [Срок оценки: At baseline and after 4 weeks]
• Incidence of OCT-biomarker hyper-reflective foci (HRF) [Срок оценки: At baseline and after 4 weeks]
• Incidence of OCT-biomarker subretinal fluid (SRF) [Срок оценки: At baseline and after 4 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Швеция · 2 центра

• Sahlgrenska University Hospital, Department of Ophthalmology — Mölndal
• Ögonmottagning Mölndal/SU — Mölndal

Идентификаторы

NCT: NCT06984822 · BiomarkerOCT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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