Clinical trial NCT00344253: Randomized, Controlled Trial to Test the Efficacy of Interferon Beta in the Treatment of Intermediate Uveitis
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uveitis, Intermediate
Macular Edema
Multiple Sclerosis
Keywords: Uveitis
Macular Edema
Interferon
Multiple Sclerosis
Encephalomyelitis disseminata (ED)
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Serono GmbH
First posted: 2006-06-26
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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. .

Eligibility 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

Primary outcomes:
measure: Change in visual acuity (3 lines ETDRS)at month 1,3,6 and 12
timeFrame: at month 1,3,6 and 12
Secondary outcomes:
measure: Reduction of macular edema (OCT)
timeFrame: at month 1,3,6 and 12
measure: Reduction intraocular inflammation (2 step change, SUN classification)
timeFrame: at month 1,3,6 and 12
measure: Increase in retinal light sensitivity (fundus controlled perimetry)
timeFrame: at month 1,3 and 12
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Interdisciplinary Uveitis Center, University of Heidelberg
Study officials:
affiliation: Interdisciplinary Uveitis Center, University of Heidelberg
name: Matthias D Becker, MD, PhD,FEBO
role: PRINCIPAL_INVESTIGATOR
affiliation: Interdisciplinary Uveitis Center,University of Heidelberg
name: Friederike Mackensen, MD, FEBO
role: PRINCIPAL_INVESTIGATOR
affiliation: Interdisciplinary Uveitis Center,University of Heidelberg
name: Regina Max, MD
role: STUDY_DIRECTOR
References:
citation: Becker MD, Heiligenhaus A, Hudde T, Storch-Hagenlocher B, Wildemann B, Barisani-Asenbauer T, Thimm C, Stubiger N, Trieschmann M, Fiehn C. Interferon as a treatment for uveitis associated with multiple sclerosis. Br J Ophthalmol. 2005 Oct;89(10):1254-7. doi: 10.1136/bjo.2004.061119.