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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00269698




Registration number
NCT00269698
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:
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

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)

Funding & Sponsors
Primary sponsor type
Other
Name
JHSPH Center for Clinical Trials
Address
Country

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/study/NCT00269698
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00269698