Status:
COMPLETED
Randomized, Controlled Trial to Test the Efficacy of Interferon Beta in the Treatment of Intermediate Uveitis
Lead Sponsor:
Heidelberg University
Collaborating Sponsors:
Serono GmbH
Conditions:
Uveitis, Intermediate
Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 Oe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00344253
Start Date
March 1 2006
End Date
January 1 2012
Last Update
December 3 2012
Active Locations (1)
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1
Interdisciplinary Uveitis Center, University of Heidelberg
Heidelberg, Germany, 69120