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

This study has been completed.
Sponsor:
Collaborator:
Serono GmbH
Information provided by (Responsible Party):
Friederike Mackensen, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00344253
First received: June 22, 2006
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Uveitis, Intermediate
Macular Edema
Multiple Sclerosis
Drug: Interferon beta
Drug: Methotrexate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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)

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Change in visual acuity (3 lines ETDRS)at month 1,3,6 and 12 [ Time Frame: at month 1,3,6 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction of macular edema (OCT) [ Time Frame: at month 1,3,6 and 12 ] [ Designated as safety issue: No ]
  • Reduction intraocular inflammation (2 step change, SUN classification) [ Time Frame: at month 1,3,6 and 12 ] [ Designated as safety issue: No ]
  • Increase in retinal light sensitivity (fundus controlled perimetry) [ Time Frame: at month 1,3 and 12 ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: March 2006
Study Completion Date: January 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Interferon beta 3x weekly
Drug: Interferon beta
Active Comparator: 2
Methotrexate sc 20 mg weekly
Drug: Methotrexate

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. .

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344253

Locations
Germany
Interdisciplinary Uveitis Center, University of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Serono GmbH
Investigators
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

Additional Information:
Publications:
Responsible Party: Friederike Mackensen, PD Dr. med., University of Heidelberg
ClinicalTrials.gov Identifier: NCT00344253     History of Changes
Other Study ID Numbers: EudraCT-Number: 2004-004403-37
Study First Received: June 22, 2006
Last Updated: November 30, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heidelberg University:
Uveitis
Macular Edema
Interferon
Multiple Sclerosis
Encephalomyelitis disseminata (ED)

Additional relevant MeSH terms:
Pars Planitis
Chorioretinitis
Encephalomyelitis
Macular Edema
Multiple Sclerosis
Sclerosis
Uveitis
Uveitis, Intermediate
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Brain Diseases
Central Nervous System Diseases
Central Nervous System Infections
Choroid Diseases
Choroiditis
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Encephalitis
Eye Diseases
Immune System Diseases
Macular Degeneration
Nervous System Diseases
Panuveitis
Pathologic Processes
Retinal Degeneration
Retinal Diseases
Retinitis
Uveal Diseases
Uveitis, Posterior
Interferon-beta

ClinicalTrials.gov processed this record on November 25, 2014