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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Interferon beta

Methotrexate

About this trial

This is an interventional treatment trial for Uveitis, Intermediate focused on measuring Uveitis, Macular Edema, Interferon, Multiple Sclerosis, Encephalomyelitis disseminata (ED)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Interdisciplinary Uveitis Center, University of Heidelberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Interferon beta 3x weekly

Methotrexate sc 20 mg weekly

Outcomes

Primary Outcome Measures

Change in visual acuity (3 lines ETDRS)at month 1,3,6 and 12

Secondary Outcome Measures

Reduction of macular edema (OCT)

Reduction intraocular inflammation (2 step change, SUN classification)

Increase in retinal light sensitivity (fundus controlled perimetry)

Full Information

NCT ID

NCT00344253

First Posted

June 22, 2006

Last Updated

November 30, 2012

Sponsor

Heidelberg University

Collaborators

Serono GmbH

1. Study Identification

Unique Protocol Identification Number

NCT00344253

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Heidelberg University

Collaborators

Serono GmbH

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uveitis, Intermediate, Macular Edema, Multiple Sclerosis

Keywords

Uveitis, Macular Edema, Interferon, Multiple Sclerosis, Encephalomyelitis disseminata (ED)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Experimental

Arm Description

Interferon beta 3x weekly

Arm Title

2

Arm Type

Active Comparator

Arm Description

Methotrexate sc 20 mg weekly

Intervention Type

Drug

Intervention Name(s)

Interferon beta

Intervention Type

Drug

Intervention Name(s)

Methotrexate

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Reduction of macular edema (OCT)

Time Frame

at month 1,3,6 and 12

Title

Reduction intraocular inflammation (2 step change, SUN classification)

Time Frame

at month 1,3,6 and 12

Title

Increase in retinal light sensitivity (fundus controlled perimetry)

Time Frame

at month 1,3 and 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthias D Becker, MD, PhD,FEBO

Organizational Affiliation

Interdisciplinary Uveitis Center, University of Heidelberg

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Friederike Mackensen, MD, FEBO

Organizational Affiliation

Interdisciplinary Uveitis Center,University of Heidelberg

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Regina Max, MD

Organizational Affiliation

Interdisciplinary Uveitis Center,University of Heidelberg

Official's Role

Study Director

Facility Information:

Facility Name

Interdisciplinary Uveitis Center, University of Heidelberg

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

16170111

Citation

Becker MD, Heiligenhaus A, Hudde T, Storch-Hagenlocher B, Wildemann B, Barisani-Asenbauer T, Thimm C, Stubiger N, Trieschmann M, Fiehn C. Interferon as a treatment for uveitis associated with multiple sclerosis. Br J Ophthalmol. 2005 Oct;89(10):1254-7. doi: 10.1136/bjo.2004.061119.

Results Reference

background

Links:

URL

http://www.klinikum.uni-heidelberg.de/Home.108029.0.html

Description

Homepage with further information and downloads

Uveitis, Intermediate, Macular Edema, Multiple Sclerosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial