Assessment of Biomarker Profile in Diabetic Macular Edema in Response to Treatment With Intravitreal Aflibercept
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Measure biomarkers in aqueous humor from individuals with DME
研究概览
简要总结
To assess the biomarker profile in diabetic macular edema patients in response to intravitreal aflibercept injection. Patients with diabetic macular edema who meet study requirements will receive monthly intravitreal injections of aflibercept as approved by FDA for a period of 6 months. A small quantity of fluid will be removed from the vitreous at each injection for laboratory evaluation of biomarkers present before, during and after treatment with aflibercept.
详细描述
Study objective is to better understand the pathophysiology of diabetic macular edema (DME) by defining the factors that participate in the disease process or may be good biomarkers for disease progression. Study will investigate the temporal relationship between the course of treatment with anti-VEGF therapy and levels of candidate biomarkers previously identified to determine which biomarkers are affected by anti-VEGF therapy with aflibercept. Study will correlate response to therapy to particular biomarkers and attempt to identify those associated with resistance to therapy for DME. Biomarker data will be correlated with serial clinical evaluation of disease progression. 40 subjects with clinically significant DME who plan to undergo anti-VEGF therapy will be treated with intravitreal aflibercept monthly for 6 months. At each visit aqueous humor will be collected and stored (6 samples per patient). At termination of study all specimens will be analyzed for biomarkers identified from previous studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current diagnosis type 1 or type 2 diabetes
- •Clinical DME as assessed by OCT
- •Well controlled glaucoma on medications but not on prostaglandin analogues
- •Mild Age Related Macular Degeneration (AMD)
- •Visual acuity between 73 and 5 ETDRS letters (20/40 -20/800 on eye chart)
- •Willing and able to participate and to comply with clinic visits and procedures
- •Provide signed informed consent
排除标准
- •Unwillingness to participate or inability to understand or sign informed consent
- •Poor eye fluid that would preclude adequate testing
- •Prior intraocular treatment with anti-VEGF or focal laser treatment within 90 days
- •Corticosteroid injections within 120 days
- •Active proliferative diabetic retinopathy
- •Intraocular pressure greater than 25 mm Hg
- •Any previous vitrectomy surgery
- •Current use of systemic anti-VEGF agents
- •Shallow anterior eye chamber in eye with natural lens
- •Non-diabetic related macular swelling (retinal vein occlusion)
- •History of ocular disease
- •Systemic disease other than diabetes mellitus
- •Pregnant or breast feeding women
- •Sexually active men or women of childbearing potential who are unwilling to practice adequate birth control during study
结局指标
主要结局
Measure biomarkers in aqueous humor from individuals with DME
时间窗: 2 years
Identify temporal effects of treatment with intravitreal afflibercept
次要结局
未报告次要终点