NCT00380172Unknown不适用
A Multicenter, Open Label, Prospective Study to Determine Safety and Efficacy Over an Additional 12-Month Period With Non-Exudative Age-Related Macular Degeneration (With Follow-on to 12-Months)
适应症
试验速览
- 阶段
- 不适用
- 发起方
- OccuLogix
- 入组人数
- 120
- 试验地点
- 17
- 主要终点
- The primary objective of this study is to evaluate the change from baseline and ETDRS visual acuity in subjects with non-exudative AMD who participated in AMD-02-99.
研究概览
简要总结
The purpose of these studies are to evaluate the effect on vision in subjects with AMD who received active and placebo treatment in the MIRA-1 study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have participated in treatment arm of MIRA-1 trial and completed 4 treatments and 6 and 9 month follow up visits.
- •Dry AMD in at least one eye.
- •Available for study duration of 12 months.
- •Weigh >110 lbs.
- •If on lipid-lowering medication must remain on for duration of trial. If not, must agree to not initate during trial.
- •Normal Pt/ PTT. If on coumadin, at the discretion of the investigator.
- •Must be highly motivated, alert and oriented, and able to provide consent.
- •Agree to discontinue current ocular vitamin regimen and take uniform supplement provided by the sponsor.
排除标准
- •Both eyes wet AMD.
- •Condition limiting view of the fundus.
- •Poor general health or unstable diseases.
- •HCT < 35%, evidence of active bleeding, platelet count <100000 K/uL, prolonged Pt/ PTT, or significant coagupapathies.
- •significant cardiac problems.
- •Uncontrolled hypertension.
- •History of CVA of TIA within a year.
- •Significant hepatic, renal, or pulmonary disease, or insulin dependent diabetes.
- •Allergy to fluorescein sodium and indocyanine green (ICG), heparin, ACDA, local anesthetics, or adhesive tape.
- •Pregnant or breastfeeding women, or women of childbearing potential not using chemical or mechanical contraception.
- •Investigation trial within 30 days.
- •Major surgery within 30 days.
- •Unwilling to adhere to visit schedule.
- •Unstable medical of psychological condition.
结局指标
主要结局
The primary objective of this study is to evaluate the change from baseline and ETDRS visual acuity in subjects with non-exudative AMD who participated in AMD-02-99.
次要结局
- The secondary objective of this study is to evaluate the safety of rheopheresis filtration treatments in subjects with non-exudative AMD as measured by AE's early DC's and Lab evaluations.
研究者
研究点 (17)
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