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

Heidelberg University

Status and phase: Completed; Phase 3

Conditions: Multiple Sclerosis; Uveitis, Intermediate; Macular Edema

Treatments: Drug: Interferon beta; Drug: Methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT00344253

EudraCT-Number: 2004-004403-37

Details and patient eligibility

About

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.

Full 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. .

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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19 participants in 2 patient groups

1

Experimental group

Description:

Interferon beta 3x weekly

Treatment:

Drug: Interferon beta

2

Active Comparator group

Description:

Methotrexate sc 20 mg weekly

Treatment:

Drug: Methotrexate