Randomized, Controlled Trial to Test the Efficacy of Inte... | NCT00344253

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

NCT00344253

Sponsor

Heidelberg University

Status

Completed

Last Update Posted

Dec 3, 2012Estimated

Enrollment

19Actual

Phase

Phase 3

Conditions

Uveitis, Intermediate
Macular Edema
Multiple Sclerosis

Interventions

Interferon beta
Methotrexate

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Mar 2011Actual

Completion Date

Jan 2012Actual

First Submitted Date

Jun 22, 2006

First Submission Date that Met QC Criteria

Jun 22, 2006

First Posted Date

Jun 26, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2012

Last Update Posted Date

Dec 3, 2012Estimated

Name	Class
Serono GmbH	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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. .

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Interferon beta 3x weekly	Drug: Interferon beta
2	Active Comparator	Methotrexate sc 20 mg weekly	Drug: Methotrexate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interferon beta	Drug		1
Methotrexate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in visual acuity (3 lines ETDRS)at month 1,3,6 and 12		at month 1,3,6 and 12

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthias D Becker, MD, PhD,FEBO	Interdisciplinary Uveitis Center, University of Heidelberg	Principal Investigator
Friederike Mackensen, MD, FEBO	Interdisciplinary Uveitis Center,University of Heidelberg	Principal Investigator
Regina Max, MD	Interdisciplinary Uveitis Center,University of Heidelberg	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Interdisciplinary Uveitis Center, University of Heidelberg		Heidelberg		69120	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16170111	Background	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.

ID	Term
D014603	Uveal Diseases
D005128	Eye Diseases
D008268	Macular Degeneration
D012162	Retinal Degeneration

ID	Term
D016899	Interferon-beta
D008727	Methotrexate

ID	Term
D007370	Interferon Type I
D007372	Interferons
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins

ID	Term
D015867	Uveitis, Intermediate
D008269	Macular Edema
D009103	Multiple Sclerosis
D014605	Uveitis