NCT00791427已完成不适用
ERG/EOG Study in AMD Patients Treated With Ranibizumab
Retina Center, Minnesota1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- ERG/EOG
研究概览
简要总结
This is an open-label study assessing electrophysiologic testing of the retina with Electoretinogram (ERG) /Electrooculogram (EOG) tests in patients with exudative age-related macular degeneration (AMD). The standard FDA-approved treatment for wet AMD is ranibizumab (Lucentis). This study focuses on the ERG and EOG tests to evaluate retinal responses to ranibizumab treatment in AMD.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study
- •Age >55 years
- •Patients to be included in the study must have AMD with choroidal neovascularization
- •BCVA between 20/20 - 20/400
- •Lesion size less than or equal to 12 MPS disc areas
排除标准
- •Prior treatment with an anti-VEGF agent within 6 months of enrollment in this study
- •Pregnancy (positive pregnancy test)
- •Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch
- •Prior enrollment in the study
- •Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- •Participation in another simultaneous medical investigation or trial
- •Media insufficient to obtain a view
- •Other causes of CNV not related to AMD
- •Active ocular or peri-ocular infection
- •Ocular surgery within 1 month prior to the study
研究组 & 干预措施
AMD Patients
干预措施: Ranibizumab (Drug)
结局指标
主要结局
ERG/EOG
时间窗: 1 year
次要结局
未报告次要终点
研究者
Abdhish R. Bhavsar, M.D.
President/Physician/Owner
Retina Center, Minnesota
研究点 (1)
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