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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Retinal health in multiple sclerosis patients prescribed copaxone
研究概览
简要总结
This is a prospective, observational, single-blinded, longitudinal, 24-month OCT study of the evolution of axonal loss, as evidenced by loss of RNFLT and TMV, in RRMS patients treated with GA and in healthy controls.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.)
结局指标
主要结局
Retinal health in multiple sclerosis patients prescribed copaxone
时间窗: 24 months
Participants will have an OCT retinal health will be determined by degree of axonal loss.
次要结局
- Measuring disability progression(24 months)
研究者
Robert Zivadinov, MD, PhD
Director, Buffalo Neuroimaging Analysis Center, Professor
University at Buffalo