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临床试验/NCT01851434
NCT01851434终止不适用

Natural History of Optic Neuritis

National Institute of Neurological Disorders and Stroke (NINDS)3 个研究点 分布在 2 个国家目标入组 8 人开始时间: 2013年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
8
试验地点
3
主要终点
The primary outcome measure is the RNFL thickness in the affected eye 12 months after optic neuritis

研究概览

简要总结

Background:

  • Optic neuritis often is a symptom of multiple sclerosis (MS). Many people who experience optic neuritis are later diagnosed with MS. MS disease activity seen on magnetic resonance imaging (MRI) scans is often greater than that seen in tests given during regular doctor's visits. Even though MRI is a helpful tool for studying optic neuritis and MS, more information is needed on how MS symptoms show up on MRI scans. Researchers want to use MRI scans to track changes in the optic nerve after an optic neuritis episode. This approach will help them study the relationship between optic neuritis and MS.

Objectives:

  • To collect more information about the relationship between optic neuritis and multiple sclerosis.

Eligibility:

  • Individuals between 18 and 50 years of age who have new optic neuritis.
  • Individuals between 18 and 50 years of age who have new symptoms of MS other than optic neuritis.
  • Healthy volunteers between 18 and 50 years of age.

Design:

  • Participants will be screened with a physical exam and medical history. They may provide blood or urine samples.
  • Participants with optic neuritis or other MS symptoms will have a baseline study visit. They will have a physical exam and full eye exam. To look for signs of MS, they will have evoked potential tests to see how the body responds to stimulation. They will also have an MRI scan to study any changes in the brain and optic nerves.
  • After the first visit, participants will have steroid treatment for 5 days for the optic neuritis.
  • Additional study visits will be given 1, 3, 6, 9, and 12 months after the baseline visit. The tests from the first visit, including the MRI scans, will be repeated at these visits.
  • Healthy volunteers will have a baseline study visit. They will have a physical exam and full eye exam. They will have evoked potential tests to see how the body responds to stimulation. They will also have an MRI scan to study any changes in the brain and optic nerves.
  • Healthy volunteers will have additional study visits 2 and 11 months after the baseline visit. The tests from the first visit, including the MRI scans, will be repeated at these visits.

详细描述

Objective

The goals of this pilot study are:

  1. To assess the degree to which subacute changes in clinical, electrophysiological, and imaging measures can robustly predict retinal neuronal loss 12 months after acute optic neuritis.
  2. To construct a composite score that integrates these subacute changes, can itself robustly predict retinal neuronal loss 12 months after acute optic neuritis, can be validated in future trials, and is likely to be modulated by drugs that promote tissue repair and neuroprotection in multiple sclerosis (MS).
  3. To evaluate the usefulness of specialized magnetic resonance imaging (MRI) measures of the optic nerve in future clinical trials of drugs designed to promote tissue repair and neuroprotection. The primary hypothesis of the study is that peripapillary retinal nerve fiber layer (RNFL) thickness, which is generally agreed to reflect the integrity of optic nerve axons following optic neuritis, and which can be measured using spectral-domain optical coherence tomography (OCT) in the affected eye 12 months following optic neuritis, can be robustly predicted by changes in RNFL thickness between 1 and 3 months following symptom onset.

Study Population

The following cohorts will be recruited at each of the three study sites:

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 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The primary outcome measure is the RNFL thickness in the affected eye 12 months after optic neuritis

时间窗: 12 months after optic neuritis

RNFL thickness in the affected eye 12 months after optic neuritis.

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (3)

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