Multicenter Uveitis Steroid Treatment (MUST) Trial

Uveitis Clinical Trial

— MUST  

Official title:

Multicenter Uveitis Steroid Treatment (MUST) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132691
• Other study ID #: NEI-106
• Secondary ID: U10EY0146601U10E
• Status: Completed
• Phase: Phase 4
• First received: August 19, 2005
• Last updated: June 22, 2012
• Start date: September 2005
• Est. completion date: December 2010

Study information

• Verified date: June 2012
• Source: JHSPH Center for Clinical Trials
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Other known NCT identifiers

• NCT00269698

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Uveitis

Intervention

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.
• oral corticosteroid with immunosuppressive agents as needed
Prednisone

Locations

Country	Name	City	State
Australia	Royal Victoria Eye & Ear Hospital	East Melbourne
United Kingdom	United Kingdom Institute of Ophthalmology	London
United States	Kellogg Eye Center, University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Wilmer Eye Institute, Johns Hopkins University	Baltimore	Maryland
United States	National Eye Institute, NIH	Bethesda	Maryland
United States	Massachusetts Eye Research & Surgery Institute	Cambridge	Massachusetts
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Illinois at Chicago Eye Center	Chicago	Illinois
United States	Texas Retina Associates	Dallas	Texas
United States	Duke Eye Center, Duke University	Durham	North Carolina
United States	Vitreoretinal Consultants	Houston	Texas
United States	Jacobs Retina Center, UCSD	La Jolla	California
United States	Doheny Eye Institute, USC	Los Angeles	California
United States	Jules Stein Eye Institute, UCLA	Los Angeles	California
United States	Anne Bates Leach Eye Hospital, University of Miami Miller School of Medicine	Miami	Florida
United States	New York Eye and Ear Infirmary	New York	New York
United States	Virginia Eye Consultants	Norfolk	Virginia
United States	Scheie Eye Institute, University of Pennsylvania	Philadelphia	Pennsylvania
United States	John A. Moran Eye Center, University of Utah	Salt Lake City	Utah
United States	Proctor Foundation, UCSF	San Francisco	California
United States	Barnes Retina Institute	St. Louis	Missouri
United States	University of South Florida	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
JHSPH Center for Clinical Trials	National Eye Institute (NEI)

Countries where clinical trial is conducted

United States,  Australia,  United Kingdom, 

References & Publications (1)

Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group, Kempen JH, Altaweel MM, Holbrook JT, Jabs DA, Louis TA, Sugar EA, Thorne JE. Randomized comparison of systemic anti-inflammatory therapy versus fluocinolone acetonide implant for intermedi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Best-corrected Visual Acuity (Change in the Numbers of Letters Read From a Standard ETDRS Eye Chart) From Baseline to 24 Months in Eyes With Uveitis	Best-corrected visual acuity was measured as the number of letters read from standard logarithmic visual acuity charts by study-certified examiners who were masked to treatment. Visual acuity was measured at all study visits. The primary outcome was eye-specific change in visual acuity from baseline to 2-year follow-up. Positive change values indicate improved vision while negative change values indicate vision has gotten worse. A change of 7.5 letters is considered clinically meaningful.	24 months	No
Secondary	Macular Edema	center point macular thickness >= 240 micrometers assessed on OCT (Stratus OCT-3 [Carl Zeiss Meditec, Dublin, CA]) as graded by Central Reading Center	24 months	No
Secondary	Uveitis Activity	Uveitis activity was determined by clinician assessment at each study visit. The study ophthalmologist evaluated each eye as active, inactive/never had uveitis or cannot assess.	24 months	No
Secondary	Intraocular Pressure - Incident IOP Greater Than or Equal to 30 mm Hg		24 months	Yes
Secondary	Intraocular Pressure - Incident IOP Greater Than or Equal to 24 mm Hg		24 months	Yes
Secondary	Intraocular Pressure - Incident IOP Elevation >= 10 mmHg Above Baseline		24 months	Yes
Secondary	Glaucoma - Incident	Glaucoma was diagnosed by a glaucoma specialist through review of visual fields, clinical data, and fundus images.	24 months	Yes
Secondary	Intraocular Pressure (IOP) - Incident Use of IOP-lowering Medical Therapy (Percentage of Eyes With Uveitis That Were Not Being Treated With IOP-lowering Medical Therapy at Baseline and Underwent IOP Lowering Therapy During the 24 Month Follow-up.	The percentage of subjects who used topical or systemic treatment for elevated IOP at any time during the 2 year follow-up and were not on IOP-lowering therapy at baseline is reported.	24 months	Yes
Secondary	Intraocular Pressure - IOP-lowering Surgery		24 months	Yes
Secondary	Cataract - Incident Cataract		24 months	No
Secondary	Change in Self-reported Vision-related Function as Measured by the National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ 25) Vision Targeted Composite Score From Baseline to 24 Months	The NEI-VFQ 25 measures the effect of visual disability/symptoms with generic health and task-oriented domains. The range for the composite score is 0 to 100; higher scores are associated with better visual function. A change of 4 to 6 points is considered to be a clinically meaningful difference.	24 months	No
Secondary	Change in SF-36 Mental Component Score From Baseline to 24 Months	Self-reported health related QoL was measured with the SF 36 survey. The mental component score for the SF 36 is a summary measure of mental health primarily based on the social functioning, role emotional, mental health and vitality domains. The score is scaled to a population norm with a mean of 50 and standard deviation of 10. Higher scores represent better outcomes. The mean change in scores between baseline and 24 months was calculated for each treatment group.	24 months	No
Secondary	Change in SF-36 Physical Component Score From Baseline to 24 Months	Self-reported health related QoL was measured with the SF 36 survey. The physical component score for the SF 36 is a summary measure of physical health primarily based on the physical functioning, role physical, bodily pain and general health domains of the survey. The score is scaled to a population norm with a mean of 50 and standard deviation of 10. Higher scores represent better outcomes. The mean change in scores between baseline and 24 months was calculated for each treatment group. A 3 to 5 point difference is considered to be clinically meaningful.	24 months	No
Secondary	Hyperlipidemia - Incident	LDL greater than or equal to 160 mg/mL	24 months	Yes
Secondary	Hypertension Diagnosis Requiring Treatment		24 months	Yes
Secondary	Diabetes Mellitus		24 months	Yes
Secondary	Mortality		24 months	Yes

External Links

•   MUST, JHU, Center for Clinical Trials