Evaluation of Serum and Ocular Coherence Tomography Biomarkers in Patients With Diabetic Macular Edema Treated With Anti-VEGF or Dexamethasone Implant
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Serum levels of Vascular Endothelial Growth Factor (VEGF)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Anti-VEGF treated patients
Patients with ongoing anti-VEGF treatment
干预措施: Anti-VEGF treatment (Drug)
Patients not previously treated for DME
Treatment-naive patients (neither anti-VEGF treatment nor Dexamethasone implant treatment)
干预措施: Treatment with intravitreal anti-VEGF OR Dexamethasone implant (Other)
Dexamethasone treated patients
Patients with ongoing Dexamethasone implant treatment
干预措施: Dexamethasone implant (Device)
结局指标
主要结局
Serum levels of Vascular Endothelial Growth Factor (VEGF)
时间窗: At baseline (and for group 3. naive patients also after 4 weeks)
Serum levels of VEGF
Serum levels of interleukin 6 (IL-6)
时间窗: At baseline (and for group 3. naive patients also after 4 weeks)
Serum levels of IL-6
Serum levels of interleukin 8 (IL-8)
时间窗: 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)
时间窗: At baseline (and for group 3. naive patients also after 4 weeks)
Serum levels of MCP-1
Serum levels of angiopoietin 2 (Ang-2)
时间窗: At baseline (and for group 3. naive patients also after 4 weeks)
Serum levels of Ang-2
Serum levels of placental growth factor (PlGF)
时间窗: 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)
时间窗: 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)
时间窗: At baseline (and for group 3. naive patients also after 4 weeks)
Serum levels of ICAM-1
次要结局
- Incidence of OCT-biomarker disorgani-zation of retinal inner layers (DRIL)(At baseline and after 4 weeks)
- Incidence of OCT-biomarker subretinal fluid (SRF)(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)