Optic Neuritis Treatment Trial (ONTT)
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| ClinicalTrials.gov Identifier: NCT00000146 |
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Recruitment Status : Unknown
Verified October 2003 by National Eye Institute (NEI).
Recruitment status was: Active, not recruiting
First Posted : September 24, 1999
Last Update Posted : June 5, 2006
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Sclerosis Optic Neuritis | Drug: Methylprednisolone Drug: Prednisone | Phase 3 |
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 patient's acuity recovers to 20/20, 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 mg/kg/day) for 14 days
- Intravenous methylprednisolone (250 mg every 6 hours) for 3 days, followed by oral prednisone (1 mg/kg/day) 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 Type : | Interventional (Clinical Trial) |
| Allocation: | Randomized |
| Masking: | Single |
| Primary Purpose: | Treatment |
| Study Start Date : | July 1988 |
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| Ages Eligible for Study: | 18 Years to 46 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
The major eligibility criteria for enrollment into the ONTT included the following:
Age range of 18 to 46 years
Acute unilateral optic neuritis with visual symptoms for 8 days or less
A relative afferent pupillary defect and a visual field defect in the affected eye
No previous episodes of optic neuritis in the affected eye
No previous corticosteroid treatment for optic neuritis or multiple sclerosis
No systemic disease other than multiple sclerosis that might be the cause of the optic neuritis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000146
| United States, Arkansas | |
| University of Arkansas | |
| Little Rock, Arkansas, United States | |
| United States, California | |
| California Pacific Medical Center | |
| San Francisco, California, United States | |
| United States, District of Columbia | |
| Georgetown University | |
| Washington, District of Columbia, United States | |
| United States, Florida | |
| University of Florida | |
| Gainesville, Florida, United States | |
| United States, Illinois | |
| University of Illinois | |
| Chicago, Illinois, United States | |
| United States, Iowa | |
| University of Iowa | |
| Iowa City, Iowa, United States | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States | |
| Michigan State University | |
| East Lansing, Michigan, United States | |
| United States, New York | |
| New York University | |
| New York, New York, United States | |
| United States, North Carolina | |
| Duke University | |
| Durham, North Carolina, United States | |
| United States, Oregon | |
| Devers Eye Institute | |
| Portland, Oregon, United States | |
| United States, Pennsylvania | |
| Wills Eye Hospital | |
| Philadelphia, Pennsylvania, United States | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States | |
| United States, Washington | |
| Swedish Medical Center | |
| Seattle, Washington, United States | |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00000146 |
| Other Study ID Numbers: |
NEI-47 |
| First Posted: | September 24, 1999 Key Record Dates |
| Last Update Posted: | June 5, 2006 |
| Last Verified: | October 2003 |
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Multiple Sclerosis Neuritis Optic Neuritis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Optic Nerve Diseases Cranial Nerve Diseases Eye Diseases Prednisone |
Methylprednisolone Methylprednisolone Acetate Methylprednisolone Hemisuccinate Prednisolone Prednisolone acetate Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics |