Studying the Effects of Copaxone on Retinal Health Using Optical Tomography Over 24 Months (GAO)
A Prospective, Observational, Single-blinded, Longitudinal Optical Coherence Tomography Study of Effect of Copaxone (Glatiramer Acetate) on Retinal Nerve Fiber Layer Thickness in Patients With Relapsing-remitting Multiple Sclerosis Over 24 Months
研究概览
地位
条件
详细说明
The primary aim of this study is to explore whether treatment with Copaxone may decrease accumulation of axonal loss, as measured by retinal nerve fiber layer thickness (RNFLT) on optical coherence tomography (OCT) in patients with RRMS over 24 months and compared to a reference population of healthy controls.
The secondary objective of this study is to investigate the effect of GA on total macular volume (TMV) on OCT in patients with RRMS over 24 months. We will also explore how the 24-month changes of RNFLT and TMV on OCT relate to progression of disability, as measured by Expanded Disability Status Scale (EDSS).
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
New York
-
Buffalo、New York、美国、14203
- Buffalo Neuroimaging Analysis Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- MS patients diagnosed with clinically definite MS according to the McDonald criteria (Polman et al., 2005)
- Starting GA monotherapy (20mg/day sc) at the time of the OCT scan
- Having baseline clinical OCT scan that included RNFLT and TMV assessment at the start of the GA
- Having baseline clinical OCT scan that included RNFLT and TMV assessment (healthy controls)
- MS patients having a RR disease course (Lublin and Reingold, 1996)
- Age 18-65 (healthy controls will be matched to MS patients for age and sex)
- Signed informed consent at the 24-month follow-up
- None of the exclusion criteria
Exclusion Criteria:
- Patients who had a relapse within 30 days prior to OCT scan date
- Patients who received steroid treatment within 30 days prior to OCT scan date
- Women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study
- MS patients who used other imunomodulatory or immunosuppressant treatment other than GA during the follow-up (e.g., IFN-β, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
队列和干预
团体/队列 |
|---|
|
Copaxone
Patients with multiple sclerosis who are currently prescribed glatiramer acitate (Copaxone)
|
|
OCT
Healthy controls
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Retinal health in multiple sclerosis patients prescribed copaxone
大体时间:24 months
|
Participants will have an OCT retinal health will be determined by degree of axonal loss.
|
24 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Measuring disability progression
大体时间:24 months
|
Investigating the effect of copaxone on total macular volume on OCT in patients with RRMS.
Exploring progression of disability as measured by Expanded Disability Status Scale (EDSS).
|
24 months
|
合作者和调查者
调查人员
- 首席研究员:Robert Zivadinov, MD, PhD、Suny University at Buffalo
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.