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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00132691
Registration number
NCT00132691
Ethics application status
Date submitted
19/08/2005
Date registered
22/08/2005
Date last updated
25/11/2016
Titles & IDs
Public title
Multicenter Uveitis Steroid Treatment (MUST) Trial
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Scientific title
Multicenter Uveitis Steroid Treatment (MUST) Trial
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Secondary ID [1]
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U10EY014660
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Secondary ID [2]
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NEI-106
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Universal Trial Number (UTN)
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Trial acronym
MUST
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Uveitis
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Condition category
Condition code
Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - fluocinolone acetonide intraocular implant
Treatment: Drugs - oral corticosteroid with immunosuppressive agents as needed
Active Comparator: 1 - Immunosuppressant medication implant
Active Comparator: 2 - Systemic corticosteroids with immunosuppressant drugs as needed
Treatment: Drugs: 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.
Treatment: Drugs: oral corticosteroid with immunosuppressive agents as needed
Prednisone
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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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.
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Timepoint [1]
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24 months
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Secondary outcome [1]
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Macular Edema
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Assessment method [1]
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center point macular thickness >= 240 micrometers assessed on OCT (Stratus OCT-3 [Carl Zeiss Meditec, Dublin, CA]) as graded by Central Reading Center
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Timepoint [1]
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24 months
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Secondary outcome [2]
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Uveitis Activity
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Assessment method [2]
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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.
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Timepoint [2]
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24 months
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Secondary outcome [3]
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Intraocular Pressure - Incident IOP Greater Than or Equal to 30 mm Hg
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Assessment method [3]
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Timepoint [3]
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24 months
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Secondary outcome [4]
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Intraocular Pressure - Incident IOP Greater Than or Equal to 24 mm Hg
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Assessment method [4]
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Timepoint [4]
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24 months
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Secondary outcome [5]
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Intraocular Pressure - Incident IOP Elevation >= 10 mmHg Above Baseline
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Assessment method [5]
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Timepoint [5]
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24 months
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Secondary outcome [6]
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Glaucoma - Incident
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Assessment method [6]
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Glaucoma was diagnosed by a glaucoma specialist through review of visual fields, clinical data, and fundus images.
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Timepoint [6]
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24 months
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Secondary outcome [7]
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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.
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Assessment method [7]
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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.
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Timepoint [7]
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24 months
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Secondary outcome [8]
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Intraocular Pressure - IOP-lowering Surgery
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Assessment method [8]
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Timepoint [8]
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24 months
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Secondary outcome [9]
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Cataract - Incident Cataract
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Assessment method [9]
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Timepoint [9]
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24 months
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Secondary outcome [10]
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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
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Assessment method [10]
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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.
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Timepoint [10]
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24 months
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Secondary outcome [11]
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Change in SF-36 Mental Component Score From Baseline to 24 Months
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Assessment method [11]
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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.
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Timepoint [11]
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24 months
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Secondary outcome [12]
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Change in SF-36 Physical Component Score From Baseline to 24 Months
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Assessment method [12]
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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.
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Timepoint [12]
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24 months
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Secondary outcome [13]
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Hyperlipidemia - Incident
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Assessment method [13]
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LDL greater than or equal to 160 mg/mL
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Timepoint [13]
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24 months
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Secondary outcome [14]
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Hypertension Diagnosis Requiring Treatment
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Assessment method [14]
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Timepoint [14]
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24 months
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Secondary outcome [15]
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Diabetes Mellitus
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Assessment method [15]
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Timepoint [15]
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24 months
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Secondary outcome [16]
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Mortality
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Assessment method [16]
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Timepoint [16]
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24 months
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Eligibility
Key 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
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Minimum age
13
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2010
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Sample size
Target
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Accrual to date
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Final
255
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Victoria Eye & Ear Hospital - East Melbourne
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Recruitment postcode(s) [1]
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- East Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Georgia
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Country [4]
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United States of America
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State/province [4]
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Illinois
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Country [5]
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United States of America
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State/province [5]
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Maryland
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Country [6]
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United States of America
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State/province [6]
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Massachusetts
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Country [7]
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United States of America
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State/province [7]
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Michigan
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Country [8]
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United States of America
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State/province [8]
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Missouri
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Country [9]
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United States of America
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State/province [9]
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New York
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Country [10]
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United States of America
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State/province [10]
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North Carolina
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Country [11]
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United States of America
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State/province [11]
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Pennsylvania
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Country [12]
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United States of America
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State/province [12]
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Texas
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Country [13]
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United States of America
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State/province [13]
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Utah
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Country [14]
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United States of America
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State/province [14]
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Virginia
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Country [15]
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United Kingdom
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State/province [15]
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London
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Funding & Sponsors
Primary sponsor type
Other
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Name
JHSPH Center for Clinical Trials
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Address
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Country
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Other collaborator category [1]
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Government body
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Name [1]
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National Eye Institute (NEI)
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00132691
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Douglas Jabs, MD, MBA
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Address
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Icahn School of Medicine at Mount Sinai
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00132691
Download to PDF