NCT00000147

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

15 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1988

Completed
11.2 years until next milestone

First Submitted

Initial submission to the registry

September 23, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 1999

Completed
Last Updated

May 29, 2006

Status Verified

October 1, 1999

First QC Date

September 23, 1999

Last Update Submit

May 26, 2006

Conditions

Interventions

Eligibility Criteria

Age18 Years - 46 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (15)

University of Arkansas

Little Rock, Arkansas, United States

Location

California Pacific Medical Center

San Francisco, California, United States

Location

Georgetown University

Washington D.C., District of Columbia, United States

Location

University of Florida

Gainesville, Florida, United States

Location

University of Illinois

Chicago, Illinois, United States

Location

University of Iowa

Iowa City, Iowa, United States

Location

Johns Hopkins University

Baltimore, Maryland, United States

Location

University of Michigan

Ann Arbor, Michigan, United States

Location

Michigan State University

East Lansing, Michigan, United States

Location

New York University

New York, New York, United States

Location

Duke University

Durham, North Carolina, United States

Location

Devers Eye Institute

Portland, Oregon, United States

Location

Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Location

Baylor College of Medicine

Houston, Texas, United States

Location

Swedish Medical Center

Seattle, Washington, United States

Location

Related Publications (25)

  • Beck RW; Diehl L; Cleary PA; Optic Neuritis Study Group; The Pelli-Robson Letter Chart: Normative data for young adults., Clin Vis Sci 1993;8:207-210

    BACKGROUND
  • Cleary PA, Beck RW, Anderson MM Jr, Kenny DJ, Backlund JY, Gilbert PR. Design, methods, and conduct of the Optic Neuritis Treatment Trial. Control Clin Trials. 1993 Apr;14(2):123-42. doi: 10.1016/0197-2456(93)90015-6.

    PMID: 8500302BACKGROUND
  • Keltner JL, Johnson CA, Beck RW, Cleary PA, Spurr JO. Quality control functions of the Visual Field Reading Center (VFRC) for the Optic Neuritis Treatment Trial (ONTT). Control Clin Trials. 1993 Apr;14(2):143-59. doi: 10.1016/0197-2456(93)90016-7.

    PMID: 8500303BACKGROUND
  • Anderson MM Jr, Boly LD, Beck RW. Remote clinic/patient monitoring for multicenter trials. Optic Neuritis Study Group. Control Clin Trials. 1996 Oct;17(5):407-14. doi: 10.1016/s0197-2456(96)00021-9.

    PMID: 8932973BACKGROUND
  • Optic Neuritis Study Group; The five-year risk of multiple sclerosis after optic neuritis. Experience of the Optic Neuritis Treatment Trial., Neurology (in press)

    BACKGROUND
  • Visual function 5 years after optic neuritis: experience of the Optic Neuritis Treatment Trial. The Optic Neuritis Study Group. Arch Ophthalmol. 1997 Dec;115(12):1545-52.

    PMID: 9400788BACKGROUND
  • The clinical profile of optic neuritis. Experience of the Optic Neuritis Treatment Trial. Optic Neuritis Study Group. Arch Ophthalmol. 1991 Dec;109(12):1673-8. doi: 10.1001/archopht.1991.01080120057025.

    PMID: 1841573BACKGROUND
  • Beck RW, Cleary PA, Anderson MM Jr, Keltner JL, Shults WT, Kaufman DI, Buckley EG, Corbett JJ, Kupersmith MJ, Miller NR, et al. A randomized, controlled trial of corticosteroids in the treatment of acute optic neuritis. The Optic Neuritis Study Group. N Engl J Med. 1992 Feb 27;326(9):581-8. doi: 10.1056/NEJM199202273260901.

    PMID: 1734247BACKGROUND
  • Beck RW. Corticosteroid treatment of optic neuritis: a need to change treatment practices. The Optic Neuritis Study Group. Neurology. 1992 Jun;42(6):1133-5. doi: 10.1212/wnl.42.6.1133. No abstract available.

    PMID: 1318520BACKGROUND
  • Beck RW. The optic neuritis treatment trial. Implications for clinical practice. Optic Neuritis Study Group. Arch Ophthalmol. 1992 Mar;110(3):331-2. doi: 10.1001/archopht.1992.01080150029020. No abstract available.

    PMID: 1543448BACKGROUND
  • Beck RW, Arrington J, Murtagh FR, Cleary PA, Kaufman DI. Brain magnetic resonance imaging in acute optic neuritis. Experience of the Optic Neuritis Study Group. Arch Neurol. 1993 Aug;50(8):841-6. doi: 10.1001/archneur.1993.00540080050013.

    PMID: 8352671BACKGROUND
  • Beck RW, Cleary PA. Optic neuritis treatment trial. One-year follow-up results. Arch Ophthalmol. 1993 Jun;111(6):773-5. doi: 10.1001/archopht.1993.01090060061023.

    PMID: 8512477BACKGROUND
  • Beck RW, Cleary PA. Recovery from severe visual loss in optic neuritis. Arch Ophthalmol. 1993 Mar;111(3):300. doi: 10.1001/archopht.1993.01090030018009. No abstract available.

    PMID: 8447730BACKGROUND
  • Beck RW, Cleary PA, Trobe JD, Kaufman DI, Kupersmith MJ, Paty DW, Brown CH. The effect of corticosteroids for acute optic neuritis on the subsequent development of multiple sclerosis. The Optic Neuritis Study Group. N Engl J Med. 1993 Dec 9;329(24):1764-9. doi: 10.1056/NEJM199312093292403.

    PMID: 8232485BACKGROUND
  • Beck RW, Kupersmith MJ, Cleary PA, Katz B. Fellow eye abnormalities in acute unilateral optic neuritis. Experience of the optic neuritis treatment trial. Ophthalmology. 1993 May;100(5):691-7; discussion 697-8. doi: 10.1016/s0161-6420(13)31589-9.

    PMID: 8493012BACKGROUND
  • Chrousos GA, Kattah JC, Beck RW, Cleary PA. Side effects of glucocorticoid treatment. Experience of the Optic Neuritis Treatment Trial. JAMA. 1993 Apr 28;269(16):2110-2.

    PMID: 8468765BACKGROUND
  • Keltner JL, Johnson CA, Spurr JO, Beck RW. Baseline visual field profile of optic neuritis. The experience of the optic neuritis treatment trial. Optic Neuritis Study Group. Arch Ophthalmol. 1993 Feb;111(2):231-4. doi: 10.1001/archopht.1993.01090020085029.

    PMID: 8431161BACKGROUND
  • Beck RW, Cleary PA, Backlund JC. The course of visual recovery after optic neuritis. Experience of the Optic Neuritis Treatment Trial. Ophthalmology. 1994 Nov;101(11):1771-8. doi: 10.1016/s0161-6420(94)31103-1.

    PMID: 7800355BACKGROUND
  • Keltner JL, Johnson CA, Spurr JO, Beck RW. Visual field profile of optic neuritis. One-year follow-up in the Optic Neuritis Treatment Trial. Arch Ophthalmol. 1994 Jul;112(7):946-53. doi: 10.1001/archopht.1994.01090190094027.

    PMID: 8031275BACKGROUND
  • Beck RW. The optic neuritis treatment trial: three-year follow-up results. Arch Ophthalmol. 1995 Feb;113(2):136-7. doi: 10.1001/archopht.1995.01100020014004. No abstract available.

    PMID: 7864737BACKGROUND
  • Beck RW, Trobe JD. The Optic Neuritis Treatment Trial. Putting the results in perspective. The Optic Neuritis Study Group. J Neuroophthalmol. 1995 Sep;15(3):131-5. No abstract available.

    PMID: 8574355BACKGROUND
  • Beck RW, Trobe JD. What we have learned from the Optic Neuritis Treatment Trial. Ophthalmology. 1995 Oct;102(10):1504-8. doi: 10.1016/s0161-6420(95)30839-1. No abstract available.

    PMID: 9097798BACKGROUND
  • Rolak LA, Beck RW, Paty DW, Tourtellotte WW, Whitaker JN, Rudick RA. Cerebrospinal fluid in acute optic neuritis: experience of the optic neuritis treatment trial. Neurology. 1996 Feb;46(2):368-72. doi: 10.1212/wnl.46.2.368.

    PMID: 8614496BACKGROUND
  • Trobe JD, Beck RW, Moke PS, Cleary PA. Contrast sensitivity and other vision tests in the optic neuritis treatment trial. Am J Ophthalmol. 1996 May;121(5):547-53. doi: 10.1016/s0002-9394(14)75429-7.

    PMID: 8610798BACKGROUND
  • Cleary PA, Beck RW, Bourque LB, Backlund JC, Miskala PH. Visual symptoms after optic neuritis. Results from the Optic Neuritis Treatment Trial. J Neuroophthalmol. 1997 Mar;17(1):18-23; quiz 24-8. doi: 10.1016/s0002-9394(14)70814-1.

    PMID: 9093956BACKGROUND

MeSH Terms

Conditions

Multiple SclerosisOptic Neuritis

Interventions

MethylprednisolonePrednisone

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesOptic Nerve DiseasesCranial Nerve DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnadienediols

Study Design

Study Type
interventional
Phase
not applicable
Masking
SINGLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 23, 1999

First Posted

September 24, 1999

Study Start

July 1, 1988

Last Updated

May 29, 2006

Record last verified: 1999-10

Locations