Multicenter Uveitis Steroid Treatment (MUST) Trial - Full Text View

Sponsor:	National Eye Institute (NEI)
Information provided by:	National Eye Institute (NEI)
ClinicalTrials.gov Identifier:	NCT00132691

Purpose

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.

Condition	Intervention	Phase
Uveitis	Drug: fluocinolone acetonide intraocular implant Drug: oral corticosteroid with immunosuppressive agents as needed	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Multicenter Uveitis Steroid Treatment (MUST) Trial

Resource links provided by NLM:

Drug Information available for: Cyclophosphamide Methotrexate Fluocinolone acetonide Azathioprine sodium salt Cyclosporine Cyclosporin Mycophenolate mofetil hydrochloride Mycophenolate Mofetil Chlorambucil Azathioprine Fluocinolone

U.S. FDA Resources

Further study details as provided by National Eye Institute (NEI):

Primary Outcome Measures:

difference in visual acuity [ Time Frame: at two years of follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Retinal morphology / Intraocular inflammation / Potential ocular complications of uveitis and of therapy / Potential systemic complications of therapy / Adverse event reporting [ Time Frame: On-going ] [ Designated as safety issue: Yes ]
Mortality / Cost-effectiveness / Quality of life [ Time Frame: On-going ] [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	September 2005
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Immunosupressant medication implant	Drug: 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.
2: Active Comparator Systemic immunosuppressant	Drug: oral corticosteroid with immunosuppressive agents as needed Prednisone

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132691

Show 23 Study Locations

Sponsors and Collaborators

National Eye Institute (NEI)

Investigators

Study Chair:	Douglas Jabs, MD, MBA	Mount Sinai School of Medicine
Study Chair:	John Kempen, MD, PhD	Scheie Eye Center, University of Pennsylvania
Study Director:	Janet T Holbrook, PhD, MPH	Director of Coordinating Cener, Johns Hopkins Bloomberg School of Public Health
Study Director:	Michael Altaweel, MD	Director of Fundus Photography Reading Center, University of Wisconsin at Madison

More Information

Additional Information:

NEI Clinical Studies Database This link exits the ClinicalTrials.gov site

MUST, JHU, Center for Clinical Trials This link exits the ClinicalTrials.gov site

ISRCTN15396562 This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mount Sinai School of Medicine ( Douglas A. Jabs, MD, MBA )
Study ID Numbers:	NEI-106, 1U10EY014660-2, ISRCTN15396562
Study First Received:	August 19, 2005
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00132691 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Eye Institute (NEI):

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

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antimetabolites
Uveal Diseases
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Fluocinolone Acetonide
Eye Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cyclophosphamide

Hormones
Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions
Azathioprine
Uveitis
Therapeutic Uses
Myeloablative Agonists
Mycophenolate mofetil
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on February 08, 2010