Assessing the Modulation of Retinal Atrophy and Neurofilament Light Chain by Ofatumumab in Relapsing Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Ganglion cell inner plexiform (GCIP) atrophy in RMS relative to HCs, according to baseline sNfL levels
研究概览
简要总结
This study aims to assess whether, and the degree to which, ofatumumab modulates or reduces rates of retinal atrophy in people with relapsing-remitting MS (RMS), according to baseline serum neurofilament light chain (sNfL) levels.
详细描述
Seventy-five people with RMS who due to commence or already receiving ofatumumab therapy within 60 days of baseline will be recruited. All recruited participants will be tracked prospectively over a two-year period. Participants will complete an optical coherence tomography (OCT) scan, visual acuity (VA) assessments, EDSS, and sNfL blood level at baseline and every 6 months. Participants will be tracked prospectively for 2 years. OCT scans, sNfL levels, disability score determinations, 100% high-contrast, 2.5% and 1.25% low-contrast letter acuities will be performed every 6 months. Results from an existing cohort of approximately 75 healthy controls (HC) from a separate study undergoing annual OCT and visual function assessments will be used for comparison purposes.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 - 70 years of age
- •Have RMS as confirmed by the treating neurologist based on the 2017 revised McDonald criteria
- •be due to commence ofatumumab within 60 days of baseline OCT/VA/phlebotomy or
- •be existing patients attending the center and already receiving ofatumumab, be eligible for inclusion, and already undergoing all of the proposed study procedures.
- •Willing to sign informed consent
- •Willing to undergo phlebotomy
排除标准
- •Uncontrolled Diabetes
- •Uncontrolled Hypertension
- •Refractive errors of +/- 6 diopters
- •Other neurologic or ophthalmologic disorders
研究组 & 干预措施
People with RMS due to commence or already receiving ofatumumab therapy
75 people with RMS due to commence or already receiving ofatumumab therapy within 60 days of baseline.
干预措施: Ofatumumab (Drug)
结局指标
主要结局
Ganglion cell inner plexiform (GCIP) atrophy in RMS relative to HCs, according to baseline sNfL levels
时间窗: at least 12 months for up to 2 years
Rates of of GCIP layer thinning (µm/year) will be assessed according to baseline sNfL levels using mixed-effects linear regression models with random subject and eye-specific random intercepts and random slopes in time, using time from baseline OCT visit (in years) as a continuous variable in both unadjusted models (including time, sNfL group and their interaction) and models adjusted for the cross-sectional and longitudinal effects of covariates (age, sex, race, and history of optic neuritis) by including these variables and their respective interactions with time.
次要结局
- Outer nuclear layer (ONL) atrophy in RMS relative to HCs(at least 12 months for up to 2 years)
- Differences in the visual function scores(at least 12 months for up to 2 years)
- Inner nuclear layer (INL) atrophy in RMS relative to HCs(at least 12 months for up to 2 years)
- Differences in expanded disability status scale (EDSS) scores(at least 12 months for up to 2 years)