Multicenter Uveitis Steroid Treatment (MUST) Trial

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2010-12-31

Brief Summary

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The purpose of this study is to compare the effectiveness of standardized systemic therapy versus fluocinolone acetonide implant therapy for the treatment of severe cases of non-infectious intermediate uveitis, posterior uveitis, or panuveitis.

Detailed Description

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The MUST trial is a randomized controlled clinical trial comparing two treatments for patients with vision-threatening non-infectious intermediate uveitis, posterior uveitis, or panuveitis:

* local therapy with fluocinolone acetonide intraocular implant in affected eyes; versus
* standard therapy: systemic corticosteroid therapy supplemented, when indicated, by corticosteroid-sparing potent immuno-modulator therapy.

Study ophthalmologists, clinic coordinators, and patients will not be masked to treatment assignment. Masking will be applied to the determination of visual function at baseline, the six month visit, and thereafter . Patients will be followed until death, participant withdrawal, or a common study closeout. Patients will be seen at baseline, one month after randomization, three months after randomization, and every three months thereafter for data collection. Both ophthalmological and medical data will be collected to evaluate the outcomes of treatment of the uveitis, complications of the uveitis, and complications from therapy itself. Selected laboratory data related to the complications from systemic corticosteroid therapy will be collected.

The planned sample size of 250 patients, 125 per treatment group, is expected to give sufficient power to detect clinically important differences in visual acuity outcomes. Patients meeting the eligibility criteria detailed above will be enrolled at approximately 23 clinical centers in the United States, Australia and UK. Patients will be randomized on a 1:1 basis to one of the two treatment groups.

The MUST Research Group received additional funding at the completion of the MUST Trial to continue following patients enrolled in the study for an additional 7 years in the MUST Trial Follow-up Study (MUST FS). Since uveitis is often a chronic condition requiring long-term treatment, the objectives of the MUST FS are to evaluate outcomes of the two treatments over a longer period time. The outcomes specified for MUST FS are the same as those specified for the MUST Trial: visual acuity, ocular and systemic side effects of treatment, quality of life, and control of ocular inflammation. The primary analyses will be to compare outcomes between the original randomization groups, i.e., intention-to-treat. Secondary analyses will be based on treatment received. Study visits will be conducted every 6 months in MUST FS as opposed to every 3 months in the MUST Trial. Two analyses are planned for public release, one at 4.5 years and one after 7 years of follow-up. The Data Safety Monitoring Board reviewed and approved the analysis plan.

Conditions

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Uveitis

Keywords

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uveitis non-infectious intermediate uveitis non-infectious posterior uveitis non-infectious panuveitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Immunosuppressant medication implant

Group Type ACTIVE_COMPARATOR

fluocinolone acetonide intraocular implant

Intervention Type DRUG

RETISERT™ (fluocinolone acetonide intravitreal implant) 0.59 mg is a sterile implant designed to release fluocinolone acetonide locally to the posterior segment of the eye at a nominal initial rate of 0.6 μg/day, decreasing over the first month to a steady state between 0.3-0.4 μg/day over approximately 30 months.

2

Systemic corticosteroids with immunosuppressant drugs as needed

Group Type ACTIVE_COMPARATOR

oral corticosteroid with immunosuppressive agents as needed

Intervention Type DRUG

Prednisone

Interventions

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fluocinolone acetonide intraocular implant

RETISERT™ (fluocinolone acetonide intravitreal implant) 0.59 mg is a sterile implant designed to release fluocinolone acetonide locally to the posterior segment of the eye at a nominal initial rate of 0.6 μg/day, decreasing over the first month to a steady state between 0.3-0.4 μg/day over approximately 30 months.

Intervention Type DRUG

oral corticosteroid with immunosuppressive agents as needed

Prednisone

Intervention Type DRUG

Other Intervention Names

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NDC 24208-416-01 Permitted immunosuppressive agents: - Alkylating agents cyclophosphamide (Cytoxan) chlorambacil - Antimetabolities azathioprine (Imuran) azathioprine chlorambucil (Leukeran) methotrexate (Rheumatrex and others) mycophenolate mofetil (Cellcept) - T-cell inhibitors cyclosporine (Neoral, Sandimmune and other trade names) tacrolimus - Biologics infliximab daclizumab other biologics

Eligibility Criteria

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Inclusion Criteria

* Age 13 years or older
* Best-corrected visual acuity of hand motions or better in at least one eye with uveitis
* Intraocular pressure 24 mm Hg or less in all eyes with uveitis

Exclusion Criteria

* Inadequately controlled diabetes
* Uncontrolled glaucoma
* Advanced glaucomatous optic nerve injury
* A history of scleritis; presence of an ocular toxoplasmosis scar.
* HIV infection or other immunodeficiency disease for which corticosteroid therapy would be contraindicated according to best medical judgment

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Douglas Jabs, MD, MBA

Role: STUDY_CHAIR

Icahn School of Medicine at Mount Sinai

John Kempen, MD, PhD

Role: STUDY_CHAIR

Scheie Eye Center, University of Pennsylvania

Janet T Holbrook, PhD, MPH

Role: STUDY_DIRECTOR

Director of Coordinating Cener, Johns Hopkins Bloomberg School of Public Health

Michael Altaweel, MD

Role: STUDY_DIRECTOR

Director of Fundus Photography Reading Center, University of Wisconsin at Madison

Locations

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Jacobs Retina Center, UCSD

La Jolla, California, United States

Site Status

Doheny Eye Institute, USC

Los Angeles, California, United States

Site Status

Jules Stein Eye Institute, UCLA

Los Angeles, California, United States

Site Status

Proctor Foundation, UCSF

San Francisco, California, United States

Site Status

Anne Bates Leach Eye Hospital, University of Miami Miller School of Medicine

Miami, Florida, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

University of Illinois at Chicago Eye Center

Chicago, Illinois, United States

Site Status

Wilmer Eye Institute, Johns Hopkins University

Baltimore, Maryland, United States

Site Status

National Eye Institute, NIH

Bethesda, Maryland, United States

Site Status

Massachusetts Eye Research & Surgery Institute

Cambridge, Massachusetts, United States

Site Status

Kellogg Eye Center, University of Michigan

Ann Arbor, Michigan, United States

Site Status

Barnes Retina Institute

St Louis, Missouri, United States

Site Status

New York Eye and Ear Infirmary

New York, New York, United States

Site Status

Duke Eye Center, Duke University

Durham, North Carolina, United States

Site Status

Scheie Eye Institute, University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Texas Retina Associates

Dallas, Texas, United States

Site Status

Vitreoretinal Consultants

Houston, Texas, United States

Site Status

John A. Moran Eye Center, University of Utah

Salt Lake City, Utah, United States

Site Status

Virginia Eye Consultants

Norfolk, Virginia, United States

Site Status

Royal Victoria Eye & Ear Hospital

East Melbourne, , Australia

Site Status

United Kingdom Institute of Ophthalmology

London, , United Kingdom

Site Status

Countries

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Canada United States Australia United Kingdom

References

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