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

Study Overview
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Brief Summary
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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
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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. .

Official Title
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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)

Conditions
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Uveitis, Intermediate, Macular Edema, Multiple Sclerosis

Intervention / Treatment
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* Drug: Interferon beta
* Drug: Methotrexate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Interferon beta 3x weekly | Drug: Interferon beta<br> <br> |
| Active Comparator: 2<br>Methotrexate sc 20 mg weekly | Drug: Methotrexate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uveitis, Macular Edema, Interferon, Multiple Sclerosis, Encephalomyelitis disseminata (ED)