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Randomized, Controlled Trial to Test the Efficacy of Interferon Beta in the Treatment of Intermediate Uveitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00344253
Recruitment Status : Completed
First Posted : June 26, 2006
Last Update Posted : December 3, 2012
Sponsor:
Collaborator:
Serono GmbH
Information provided by (Responsible Party):
Friederike Mackensen, Heidelberg University

Study Description
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Brief Summary:
The purpose of this study is to investigate if interferon beta is superior to the standard treatment with Methotrexate for the treatment of intermediate uveitis and macular edema.

Condition or disease Intervention/treatment Phase
Uveitis, Intermediate Macular Edema Multiple Sclerosis Drug: Interferon beta Drug: Methotrexate Phase 3

Detailed Description:

Deuter et al were the first to show the anti-edematous effect of interferon alpha on inflammatory macular edema (Deuter C. M. E., Kötter I., Günaydin I., Zierhut M. Treatment of the Cystoid Macular Oedema in Behçet's Disease with Interferon Alfa-2a, Retina, in press). In an interventional, multi-centric pilot-study we could demonstrate a positive effect of interferon beta on ED associated uveitis, especially in reducing the macular edema. Undesired effects of the treatment were not observed.

Thus we want to test the efficacy and safety of interferon beta compared to standard treatment with methotrexate in a prospective, clinically controlled trial on patients who suffer from intermediate uveitis with inflammatory macular edema who either have associated ED or have no systemic disease association, i.e. primary uveitis. .

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : March 2006
Actual Primary Completion Date : March 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Interferon beta 3x weekly
 Drug: Interferon beta
Active Comparator: 2
Methotrexate sc 20 mg weekly
 Drug: Methotrexate


Outcome Measures
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Primary Outcome Measures :
  1. Change in visual acuity (3 lines ETDRS)at month 1,3,6 and 12 [ Time Frame: at month 1,3,6 and 12 ]

Secondary Outcome Measures :
  1. Reduction of macular edema (OCT) [ Time Frame: at month 1,3,6 and 12 ]
  2. Reduction intraocular inflammation (2 step change, SUN classification) [ Time Frame: at month 1,3,6 and 12 ]
  3. Increase in retinal light sensitivity (fundus controlled perimetry) [ Time Frame: at month 1,3 and 12 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00344253


Locations
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Germany
Interdisciplinary Uveitis Center, University of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Serono GmbH
Investigators
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Principal Investigator: Matthias D Becker, MD, PhD,FEBO Interdisciplinary Uveitis Center, University of Heidelberg
Principal Investigator: Friederike Mackensen, MD, FEBO Interdisciplinary Uveitis Center,University of Heidelberg
Study Director: Regina Max, MD Interdisciplinary Uveitis Center,University of Heidelberg
More Information
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Additional Information:

Publications:

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Responsible Party: Friederike Mackensen, PD Dr. med., Heidelberg University
ClinicalTrials.gov Identifier: NCT00344253    
Other Study ID Numbers: EudraCT-Number: 2004-004403-37
First Posted: June 26, 2006    Key Record Dates
Last Update Posted: December 3, 2012
Last Verified: November 2012
Keywords provided by Friederike Mackensen, Heidelberg University:
Uveitis
Macular Edema
Interferon
Multiple Sclerosis
Encephalomyelitis disseminata (ED)
Additional relevant MeSH terms:
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Multiple Sclerosis
Encephalomyelitis
Macular Edema
Uveitis
Uveitis, Intermediate
Pars Planitis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Macular Degeneration
 Retinal Degeneration
Retinal Diseases
Eye Diseases
Uveal Diseases
Central Nervous System Infections
Central Nervous System Diseases
Choroiditis
Choroid Diseases
Uveitis, Posterior
Panuveitis
Interferons
Interferon-beta
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents