PIIR Study: Comparison of Genetic Tests for Age-Related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Risk score from RetnaGene
研究概览
简要总结
This study is being conducted to compare two different genetic tests developed to determine an individuals risk of developing serious vision threatening complications from age-related macular degeneration (ARMD).
详细描述
There are currently two different genetic tests that have been developed for this purpose. They both look at specific DNA components to determine the risk. Participants in the study will be over the age of 60 years and caucasian as this is the population of people in which these tests have been validated. Each participant will have the study explained to them and then will be asked to sign the informed consent document if they agree to participate. They will have a dilated exam of their eyes along with photographs taken of the retina. If their doctor sees that it is necessary they will also have a special scan or a special angiogram of their eyes to look at their retina in more detail. For the genetic testing a member of the research team will use two swabs from each of the genetic companies to gently scrap some cells from the inside of the cheek. These cells will be sent to each respective lab for analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caucasian race
- •Age >/= 60 years
- •Patient's written informed consent
- •Ability to comply with the protocol procedures
排除标准
- •Race other than Caucasian
- •Age < 60 years
- •Macular or retinal pathology other than ARMD
- •Known hypersensitivity to any drug included in the treatment protocol
- •Any other severe clinical condition that in the judgment of the local investigator would place the patient at undue risk or interfere with the study completion
- •Prisoners
结局指标
主要结局
Risk score from RetnaGene
时间窗: Day 1
Risk score assigned after genetic analysis of a buccal swab by the RetnaGene (Sequenom) genetic test.
Risk score from Macula Risk
时间窗: Day 1
Risk score assigned after genetic analysis of a buccal swab by the Macula Risk genetic test.
次要结局
未报告次要终点