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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00132691




Trial ID
NCT00132691
Ethics application status
Date submitted
19/08/2005
Date registered
19/08/2005
Date last updated
13/10/2016

Titles & IDs
Public title
Multicenter Uveitis Steroid Treatment (MUST) Trial
Scientific title
Multicenter Uveitis Steroid Treatment (MUST) Trial
Secondary ID [1] 0 0
U10EY014660
Secondary ID [2] 0 0
NEI-106
Universal Trial Number (UTN)
Trial acronym
MUST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uveitis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
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
RETISERTâ„¢ (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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
Intraocular Pressure - Incident IOP Greater Than or Equal to 30 mm Hg
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Intraocular Pressure - Incident IOP Greater Than or Equal to 24 mm Hg
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
Intraocular Pressure - Incident IOP Elevation >= 10 mmHg Above Baseline
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Glaucoma - Incident - Glaucoma was diagnosed by a glaucoma specialist through review of visual fields, clinical data, and fundus images.
Timepoint [6] 0 0
24 months
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
24 months
Secondary outcome [8] 0 0
Intraocular Pressure - IOP-lowering Surgery
Timepoint [8] 0 0
24 months
Secondary outcome [9] 0 0
Cataract - Incident Cataract
Timepoint [9] 0 0
24 months
Secondary outcome [10] 0 0
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.
Timepoint [10] 0 0
24 months
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
24 months
Secondary outcome [12] 0 0
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.
Timepoint [12] 0 0
24 months
Secondary outcome [13] 0 0
Hyperlipidemia - Incident - LDL greater than or equal to 160 mg/mL
Timepoint [13] 0 0
24 months
Secondary outcome [14] 0 0
Hypertension Diagnosis Requiring Treatment
Timepoint [14] 0 0
24 months
Secondary outcome [15] 0 0
Diabetes Mellitus
Timepoint [15] 0 0
24 months
Secondary outcome [16] 0 0
Mortality
Timepoint [16] 0 0
24 months

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
Minimum age
13 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Victoria Eye & Ear Hospital - East Melbourne
Recruitment postcode(s) [1] 0 0
- East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Utah
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
United Kingdom
State/province [15] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
JHSPH Center for Clinical Trials
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Eye Institute (NEI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00132691
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Douglas Jabs, MD, MBA
Address 0 0
Icahn School of Medicine at Mount Sinai
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries