VEGF and HTRA1 DNA Polymorphisms in Neovascular AMD Pathogenesis and Response to Lucentis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 65
- 试验地点
- 3
- 主要终点
- To determine the VEGF and HTRA1 genotypes associated with improvement in visual acuity
研究概览
简要总结
The purpose of the study is to investigate whether the efficacy of Lucentis treatment for exudative age-related macular degeneration is associated with VEGF and HTRA1 DNA polymorphisms
详细描述
Treatment naive exudative AMD patients will receive Lucentis treatment as standard of care, and followed monthly for 12 months. Standard ophthalmologic exams will be performed, along with ETDRS visual acuity and optical coherence tomography (OCT). A blood sample will be obtained for DNA analysis. The primary outcome measure is change in visual acuity at 4 months after initial Lucentis treatment. Secondary outcomes are change in visual acuity and retinal thickness at 12 months.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment naive AMD patients;
- •At least 50 years of age;
- •Visual acuity between 20/40 and 20/320
排除标准
- •Pregnancy;
- •Prior enrollment in a ranibizumab clinical trial;
- •Previous therapy in either eye for AMD;
- •Concurrent eye disease that could compromise visual acuity
研究组 & 干预措施
1
Active approved treatment
干预措施: Lucentis (Drug)
结局指标
主要结局
To determine the VEGF and HTRA1 genotypes associated with improvement in visual acuity
时间窗: 4 months
次要结局
- Determine VEGF and HTRA1 genotypes associated with change or no change in visual acuity(12 months)
研究者
Paul S. Bernstein
Professor, Ophthalmology
University of Utah