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

Multiple Sclerosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00344253
• Other study ID #: EudraCT-Number: 2004-004403-37
• Status: Completed
• Phase: Phase 3
• First received: June 22, 2006
• Last updated: November 30, 2012
• Start date: March 2006
• Est. completion date: January 2012

Study information

• Verified date: November 2012
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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. .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Encephalomyelitis
• Macular Edema
• Multiple Sclerosis
• Uveitis
• Uveitis, Intermediate

Intervention

Drug:
• Interferon beta

• Methotrexate

Locations

Country	Name	City	State
Germany	Interdisciplinary Uveitis Center, University of Heidelberg	Heidelberg

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg University	Serono GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in visual acuity (3 lines ETDRS)at month 1,3,6 and 12		at month 1,3,6 and 12	No
Secondary	Reduction of macular edema (OCT)		at month 1,3,6 and 12	No
Secondary	Reduction intraocular inflammation (2 step change, SUN classification)		at month 1,3,6 and 12	No
Secondary	Increase in retinal light sensitivity (fundus controlled perimetry)		at month 1,3 and 12	No

External Links

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