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

NCT ID: NCT00344253

Last Updated: 2012-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2012-01-31

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. .

Conditions

Uveitis, Intermediate; Macular Edema; Multiple Sclerosis

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Interferon beta 3x weekly

Group Type: EXPERIMENTAL

Interferon beta

Intervention Type: DRUG

2

Methotrexate sc 20 mg weekly

Group Type: ACTIVE_COMPARATOR

Methotrexate

Intervention Type: DRUG

Interventions

Interferon beta

Intervention Type: DRUG

Methotrexate

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Serono GmbH

UNKNOWN

Sponsor Role: collaborator

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

Friederike Mackensen

PD Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthias D Becker, MD, PhD,FEBO

Role: PRINCIPAL_INVESTIGATOR

Interdisciplinary Uveitis Center, University of Heidelberg

Friederike Mackensen, MD, FEBO

Role: PRINCIPAL_INVESTIGATOR

Interdisciplinary Uveitis Center,University of Heidelberg

Regina Max, MD

Role: STUDY_DIRECTOR

Interdisciplinary Uveitis Center,University of Heidelberg

Locations

Interdisciplinary Uveitis Center, University of Heidelberg

Heidelberg, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 16170111 (View on PubMed)

Other Identifiers

EudraCT-Number: 2004-004403-37

Identifier Type: -

Identifier Source: org_study_id