NCT01213667Unknown4 期
Pharmacogenetics in Anti-VEGF Treatment Non-responders Suffering Exudative Age-related Macular Degeneration (AMD): Genetic Correlations and Intraocular Cytokine Concentrations
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Visual acuity
研究概览
简要总结
To assess genetic features and intraocular cytokine profiles of non-responders to anti-VEGF treatment of exudative age-related macular degeneration. Also to assess necessity and frequency of pro re nate medical re-treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •active subfoveal CNV related to exudative age-related macular degeneration (all subforms)
- •age > 60 years
- •visual acuity > 20/400
- •no previous treatment for AMD
排除标准
- •any previous AMD therapy
- •other CNV types (myopic, parapapillary)
- •contraindication for ranibizumab treatment
- •prior study participation for AMD
- •pregnancy / premenopausal women
研究组 & 干预措施
ranibizumab as needed
Other
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Visual acuity
时间窗: 2 years
Change in visual acuity within the observation period
次要结局
- Changes in OCT central retinal thickness / retinal volume(2 years)
- Association between treatment application delay and visual outcome(2 years)
- Association between re-treatment necessity / frequency and intraocular cytokine profiles(2 years)
- Association between treatment response and genotype(2 years)
研究者
Philipp S. Muether
MD, PhD
University of Cologne
研究点 (1)
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