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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
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
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
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
Macular Edema
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Uveitis Activity
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
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.
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
Timepoint [10] 0 0
24 months
Secondary outcome [11] 0 0
Change in SF-36 Mental Component Score From Baseline to 24 Months
Timepoint [11] 0 0
24 months
Secondary outcome [12] 0 0
Change in SF-36 Physical Component Score From Baseline to 24 Months
Timepoint [12] 0 0
24 months
Secondary outcome [13] 0 0
Hyperlipidemia - Incident
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
Sex
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
1/09/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
Accrual to date
Final
255
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Multicenter Uveitis Steroid Treatment (MUST) Trial... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00132691