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

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heidelberg University
• Collaborator: Serono GmbH
• Treatments: Interferon-beta; Interferons; Methotrexate

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