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

Phase 3

Completed

• Conditions: Uveitis, Intermediate; Macular Edema; Multiple Sclerosis
• Interventions: Drug: Interferon beta; Drug: Methotrexate

• Registration Number: NCT00344253
• Lead Sponsor: Heidelberg University

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. .

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-06-22
• Study First Submitted QC: 2006-06-22
• Study First Posted: 2006-06-26
• Primary Completion: 2011-03
• Study Completion: 2012-01
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-30
• Last Update Posted: 2012-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Interferon beta	Interferon beta 3x weekly
2	Methotrexate	Methotrexate sc 20 mg weekly

Primary Outcome Measures

Name	Time	Method
Change in visual acuity (3 lines ETDRS)at month 1,3,6 and 12	at month 1,3,6 and 12

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Interdisciplinary Uveitis Center, University of Heidelberg; 🇩🇪 Heidelberg, Germany