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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00344253 |
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Date of registration:
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22/06/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Randomized, Controlled Trial to Test the Efficacy of Interferon Beta in the Treatment of Intermediate Uveitis
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Scientific title:
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A Monocentric, Randomized, Controlled Trial to Test the Efficacy of Interferon-beta in the Treatment of Disseminated Encephalomyelitis (ED)-Associated and Primary Intermediate Uveitis in Comparison to Standard Treatment (TEAM) |
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Date of first enrolment:
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March 2006 |
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Target sample size:
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19 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00344253 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Germany
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Contacts
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Name:
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Regina Max, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Interdisciplinary Uveitis Center,University of Heidelberg |
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Name:
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Friederike Mackensen, MD, FEBO |
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Address:
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Telephone:
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Email:
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Affiliation:
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Interdisciplinary Uveitis Center,University of Heidelberg |
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Name:
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Matthias D Becker, MD, PhD,FEBO |
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Address:
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Telephone:
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Email:
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Affiliation:
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Interdisciplinary Uveitis Center, University of Heidelberg |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male and female patients age 18 and over
- Active uni- or bilateral non-infectious intermediate uveitis of at least 1 year
duration
- Visual acuity on the worse eye at least 0.1 (20/200) and maximally 0.6 (20/30) caused
by macular edema, defined by foveal thickness = 250 µm
- Either primary uveitis or diagnosis of Multiple Sclerosis
- Previous treatment with oral corticosteroids in a dose of 0.5 mg per kg bodyweight of
prednisone equivalent without sufficient success
- Previous treatment with other immunosuppressive drugs is facultative
Exclusion Criteria:
- Exclusively anterior uveitis
- Absence of macular edema
- Optic nerve atrophy after neuritis nervi optici
- Peri-or intraocular injection of corticosteroids in the previous 3 months
- Allergies against any interferon
- Depression diagnosed by a psychiatrist
- Hepatic disease
- Infectious Uveitis
- Other auto-immune diseases but MS
- Pregnancy, Lactation
- Lack of reliable contraception
- Patients with metabolic, psychiatric or neoplastic diseases
- Active diseases like asthma, psoriasis or inflammatory bowel disease who have to be
treated with corticosteroids
- primary or secondary immune deficiency
- Tuberculosis or other infectious lung diseases
- Hepatitis B or C
- Life vaccination during the trial duration
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Uveitis, Intermediate
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Macular Edema
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Multiple Sclerosis
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Intervention(s)
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Drug: Interferon beta
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Drug: Methotrexate
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Primary Outcome(s)
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Change in visual acuity (3 lines ETDRS)at month 1,3,6 and 12
[Time Frame: at month 1,3,6 and 12]
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Secondary Outcome(s)
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Increase in retinal light sensitivity (fundus controlled perimetry)
[Time Frame: at month 1,3 and 12]
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Reduction of macular edema (OCT)
[Time Frame: at month 1,3,6 and 12]
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Reduction intraocular inflammation (2 step change, SUN classification)
[Time Frame: at month 1,3,6 and 12]
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Secondary ID(s)
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EudraCT-Number: 2004-004403-37
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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