Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000147
Status:
UNKNOWN
Last Update Posted:
2006-05-29
First Post:
1999-09-23
Brief Title:
Longitudinal Optic Neuritis Study LONS
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
1999-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the beneficial and adverse effects of corticosteroid treatment for optic neuritis
To determine the natural history of vision in patients who suffer optic neuritis
To identify risk factors for the development of multiple sclerosis in patients with optic neuritis
To determine the natural history of vision in patients who suffer optic neuritis
To identify risk factors for the development of multiple sclerosis in patients with optic neuritis
Detailed Description:
Optic neuritis is an inflammatory disease of the optic nerve that typically affects young adults Women are affected more often than men It is second only to glaucoma as the most common acquired optic nerve disorder in persons younger than age 50
In this disorder closely linked to multiple sclerosis prognosis for visual recovery is generally good However return of visual function is almost never complete After resolution of optic neuritis virtually all patients show some signs of optic nerve damage and most are symptomatic Even when a patients acuity recovers to 2020 abnormalities frequently remain in other measures such as contrast sensitivity color vision and visual field
Prior to the Optic Neuritis Treatment Trial ONTT well-established guidelines for treating optic neuritis did not exist Although corticosteroids had been used to treat this disease studies to demonstrate their effectiveness had not been satisfactory Some experts advocated treatment with oral prednisone while others recommended no treatment Anecdotal reports suggested that high-dose intravenous corticosteroids might be effective
The association between optic neuritis and multiple sclerosis is well established Optic neuritis may be the first manifestation of multiple sclerosis or it may occur later in its course A strong case can be made for isolated optic neuritis being a forme fruste of multiple sclerosis based on similarities between the two in such epidemiologic factors as gender age geographic distributions cerebrospinal fluid changes histocompatibility data magnetic resonance imaging MRI changes and family history The magnitude of the risk of multiple sclerosis after optic neuritis is uncertain Previous studies have reported very disparate results with the risk being reported to be as low as 13 percent and as high as 88 percent The importance of risk factors such as age gender and MRI changes in predicting which patients with optic neuritis are most likely to develop multiple sclerosis also is unclear
The treatment phase of the study was called the Optic Neuritis Treatment Trial ONTT whereas the current long-term followup phase is called the Longitudinal Optic Neuritis Study LONS The study is being conducted at 15 clinical centers in the United States Resource centers include a data coordinating center and a visual field reading center
Patients were randomized to one of the three following treatment groups at 15 clinical centers
Oral prednisone 1 mgkgday for 14 days
Intravenous methylprednisolone 250 mg every 6 hours for 3 days followed by oral prednisone 1 mgkgday for 11 days
Oral placebo for 14 days
Each regimen was followed by a short oral taper The oral prednisone and placebo groups were double masked whereas the intravenous methylprednisolone group was single masked
Baseline testing included blood tests to evaluate for syphilis and systemic lupus erythematosus a chest x-ray to evaluate for sarcoidosis and a brain MRI scan to evaluate for changes suggestive of multiple sclerosis
The rate of visual recovery and the long-term visual outcome were both assessed by measures of visual acuity contrast sensitivity color vision and visual field at baseline at seven followup visits during the first 6 months and then yearly A standardized neurologic examination with an assessment of multiple sclerosis status was made at baseline after 6 months and then yearly
In this disorder closely linked to multiple sclerosis prognosis for visual recovery is generally good However return of visual function is almost never complete After resolution of optic neuritis virtually all patients show some signs of optic nerve damage and most are symptomatic Even when a patients acuity recovers to 2020 abnormalities frequently remain in other measures such as contrast sensitivity color vision and visual field
Prior to the Optic Neuritis Treatment Trial ONTT well-established guidelines for treating optic neuritis did not exist Although corticosteroids had been used to treat this disease studies to demonstrate their effectiveness had not been satisfactory Some experts advocated treatment with oral prednisone while others recommended no treatment Anecdotal reports suggested that high-dose intravenous corticosteroids might be effective
The association between optic neuritis and multiple sclerosis is well established Optic neuritis may be the first manifestation of multiple sclerosis or it may occur later in its course A strong case can be made for isolated optic neuritis being a forme fruste of multiple sclerosis based on similarities between the two in such epidemiologic factors as gender age geographic distributions cerebrospinal fluid changes histocompatibility data magnetic resonance imaging MRI changes and family history The magnitude of the risk of multiple sclerosis after optic neuritis is uncertain Previous studies have reported very disparate results with the risk being reported to be as low as 13 percent and as high as 88 percent The importance of risk factors such as age gender and MRI changes in predicting which patients with optic neuritis are most likely to develop multiple sclerosis also is unclear
The treatment phase of the study was called the Optic Neuritis Treatment Trial ONTT whereas the current long-term followup phase is called the Longitudinal Optic Neuritis Study LONS The study is being conducted at 15 clinical centers in the United States Resource centers include a data coordinating center and a visual field reading center
Patients were randomized to one of the three following treatment groups at 15 clinical centers
Oral prednisone 1 mgkgday for 14 days
Intravenous methylprednisolone 250 mg every 6 hours for 3 days followed by oral prednisone 1 mgkgday for 11 days
Oral placebo for 14 days
Each regimen was followed by a short oral taper The oral prednisone and placebo groups were double masked whereas the intravenous methylprednisolone group was single masked
Baseline testing included blood tests to evaluate for syphilis and systemic lupus erythematosus a chest x-ray to evaluate for sarcoidosis and a brain MRI scan to evaluate for changes suggestive of multiple sclerosis
The rate of visual recovery and the long-term visual outcome were both assessed by measures of visual acuity contrast sensitivity color vision and visual field at baseline at seven followup visits during the first 6 months and then yearly A standardized neurologic examination with an assessment of multiple sclerosis status was made at baseline after 6 months and then yearly
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None