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

November 30, 2012 updated by: Friederike Mackensen, Heidelberg University

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • Interdisciplinary Uveitis Center, University of Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Interferon beta 3x weekly
Drug: Interferon beta
ACTIVE_COMPARATOR: 2
Methotrexate sc 20 mg weekly
Drug: Methotrexate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in visual acuity (3 lines ETDRS)at month 1,3,6 and 12
Time Frame: at month 1,3,6 and 12
at month 1,3,6 and 12

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

June 22, 2006

First Submitted That Met QC Criteria

June 22, 2006

First Posted (ESTIMATE)

June 26, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2012

Last Update Submitted That Met QC Criteria

November 30, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT-Number: 2004-004403-37

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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