NCT00344253

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2006

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2006

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

December 3, 2012

Status Verified

November 1, 2012

Enrollment Period

5 years

First QC Date

June 22, 2006

Last Update Submit

November 30, 2012

Conditions

Uveitis, IntermediateMacular EdemaMultiple Sclerosis

Keywords

UveitisMacular EdemaInterferonMultiple SclerosisEncephalomyelitis disseminata (ED)

Outcome Measures

Primary Outcomes (1)

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

    at month 1,3,6 and 12

Secondary Outcomes (3)

  • 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

Study Arms (2)

1

EXPERIMENTAL

Interferon beta 3x weekly

Drug: Interferon beta

2

ACTIVE COMPARATOR

Methotrexate sc 20 mg weekly

Drug: Methotrexate

Interventions

Interferon betaDRUG
1
MethotrexateDRUG
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Interdisciplinary Uveitis Center, University of Heidelberg

Heidelberg, 69120, Germany

Location

Related Publications (1)

  • 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.

    PMID: 16170111BACKGROUND

MeSH Terms

Conditions

Uveitis, IntermediateMacular EdemaMultiple SclerosisUveitis

Interventions

Interferon-betaMethotrexate

Condition Hierarchy (Ancestors)

Uveal DiseasesEye DiseasesMacular DegenerationRetinal DegenerationRetinal DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med.

Study Record Dates

First Submitted

June 22, 2006

First Posted

June 26, 2006

Study Start

March 1, 2006

Primary Completion

March 1, 2011

Study Completion

January 1, 2012

Last Updated

December 3, 2012

Record last verified: 2012-11

Locations

DE(1)