Randomized, Controlled Trial to Test the Efficacy of Interferon Beta in the Treatment of Intermediate Uveitis
This study has been completed.
Sponsor:
University of Heidelberg
Collaborator:
Serono GmbH
Information provided by (Responsible Party):
Friederike Mackensen, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00344253
First received: June 22, 2006
Last updated: November 30, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Uveitis, Intermediate Macular Edema Multiple Sclerosis |
Drug: Interferon beta Drug: Methotrexate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
multiple sclerosis
X-linked juvenile retinoschisis
U.S. FDA Resources
Further study details as provided by University of Heidelberg:
Primary Outcome Measures:
- Change in visual acuity (3 lines ETDRS)at month 1,3,6 and 12 [ Time Frame: at month 1,3,6 and 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Reduction of macular edema (OCT) [ Time Frame: at month 1,3,6 and 12 ] [ Designated as safety issue: No ]
- Reduction intraocular inflammation (2 step change, SUN classification) [ Time Frame: at month 1,3,6 and 12 ] [ Designated as safety issue: No ]
- Increase in retinal light sensitivity (fundus controlled perimetry) [ Time Frame: at month 1,3 and 12 ] [ Designated as safety issue: No ]
| Enrollment: | 19 |
| Study Start Date: | March 2006 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Interferon beta 3x weekly
|
Drug: Interferon beta |
|
Active Comparator: 2
Methotrexate sc 20 mg weekly
|
Drug: Methotrexate |
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. .
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00344253
Locations
| Germany | |
| Interdisciplinary Uveitis Center, University of Heidelberg | |
| Heidelberg, Germany, 69120 | |
Sponsors and Collaborators
University of Heidelberg
Serono GmbH
Investigators
| Principal Investigator: | Matthias D Becker, MD, PhD,FEBO | Interdisciplinary Uveitis Center, University of Heidelberg |
| Principal Investigator: | Friederike Mackensen, MD, FEBO | Interdisciplinary Uveitis Center,University of Heidelberg |
| Study Director: | Regina Max, MD | Interdisciplinary Uveitis Center,University of Heidelberg |
More Information
Additional Information:
Publications:
| Responsible Party: | Friederike Mackensen, PD Dr. med., University of Heidelberg |
| ClinicalTrials.gov Identifier: | NCT00344253 History of Changes |
| Other Study ID Numbers: | EudraCT-Number: 2004-004403-37 |
| Study First Received: | June 22, 2006 |
| Last Updated: | November 30, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University of Heidelberg:
|
Uveitis Macular Edema Interferon Multiple Sclerosis Encephalomyelitis disseminata (ED) |
Additional relevant MeSH terms:
|
Edema Encephalomyelitis Macular Edema Multiple Sclerosis Sclerosis Uveitis Chorioretinitis Uveitis, Intermediate Pars Planitis Signs and Symptoms Encephalitis Brain Diseases Central Nervous System Diseases Nervous System Diseases Central Nervous System Infections |
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Uveal Diseases Retinitis Choroiditis Choroid Diseases Uveitis, Posterior |
ClinicalTrials.gov processed this record on May 19, 2013