Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00132691
Protocol/serial number
N/A
Study information
Scientific title
Multicenter Uveitis Steroid Treatment Trial
Acronym
MUST
Study hypothesis
Uveitis refers to several ocular disorders characterised by intraocular inflammation, which in the aggregate are a major cause of visual loss and blindness in the United States. Intermediate uveitis, posterior uveitis, and panuveitis are generally the more severe forms of uveitis, with the highest risk of vision loss, often requiring long-term systemic treatment.
1. Patients randomised to implant therapy will have better visual outcomes.
2. Patients randomised to implant therapy will have improved control of uveitis, a decreased rate of posterior segment structural complications of the uveitis (such as cystoid macular edema and epiretinal membranes), and an increased rate of corticosteroid-induced ocular complications, such as cataracts, ocular hypertension, and glaucoma.
3. Patients randomised to systemic therapy will have a higher rate of systemic complications, such as diabetes, hypertension, and osteoporosis.
4. Improved visual outcomes and the absence of systemic corticosteroid complications (and the additional treatments needed to combat them) will result in a better quality of life for patients randomised to implant therapy.
Ethics approval
Johns Hopkins Bloomberg School of Public Health Institutional Review Board (formerly known as Johns Hopkins Bloomberg School of Public Health Committee on Human Research), FDA# 00000287 (IRB ref: H.34.04.04.07.B1)
1. Protocol version 1.1, approved on the 18/05/2005
2. Protocol version 3.3, approved on the 03/09/2008
3. Protocol version 3.4, approved on the 13/08/2009
Study design
Open-label parallel-assignment randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Uveitis
Intervention
Intervention group: fluocinolone acetonide intraocular implant
Control group: oral corticosteroid with immunosuppressive agents as needed
The fluocinolone acetonide intraocular implant is a surgically implanted reservoir of corticosteroid designed to last approximately 2.5 years in order to provide long-term control of uveitis.
Total duration of follow-up: Minimum of 2 years (patients enrolled early in the study will be followed for up to 5 years)
Intervention type
Drug
Phase
Not Applicable
Drug names
Fluocinolone acetonide, corticosteroid, immunosuppressive agents
Primary outcome measures
Change in best-corrected visual acuity as measured by a logarithmic chart (measured at every study visit). Total duration of follow-up: 2 years
Secondary outcome measures
1. Occurrence of ocular complications
2. Occurrence of systemic complications
3. Control of uveitis
4. Quality of life at baseline and 6 months, assessed using the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) and the 36-item Short Form health survey (SF-36)
5. Mortality. Total duration of follow-up: 2 years.
The following tests will also be carreid out to assess the outcomes 1-3 above:
a. Eye exam/blood draw (laboratory) at every study visit
b. Visual field testing at baseline and yearly thereafter
Overall trial start date
01/12/2005
Overall trial end date
31/12/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age 13 years or older
2. Best-corrected visual acuity of hand motions or better in at least one eye with uveitis
3. Intraocular pressure 24 mmHg or less in all eyes with uveitis
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
250
Participant exclusion criteria
1. Inadequately controlled diabetes
2. Uncontrolled glaucoma
3. Advanced glaucomatous optic nerve injury
4. A history of scleritis; presence of an ocular toxoplasmosis scar
5. HIV infection or other immunodeficiency disease for which corticosteroid therapy would be contraindicated according to best medical judgment
Recruitment start date
01/12/2005
Recruitment end date
31/12/2011
Locations
Countries of recruitment
Australia, United Kingdom, United States of America
Trial participating centre
Mount Sinai School of Medicine
New York
10029-6584
United States of America
Sponsor information
Organisation
The Multicenter Uveitis Steroid Treatment Trial (MUST) Coordinating Center (USA)
Sponsor details
c/o Janet Holbrook
Johns Hopkins Center for Clinical Trials
Bloomberg School of Public Health
911 South Ann Street
Baltimore
Maryland
21231
United States of America
Sponsor type
Other
Website
Funders
Funder type
Government
Funder name
National Eye Institute
Alternative name(s)
NEI
Funding Body Type
government organisation
Funding Body Subtype
federal/national government
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
See https://clinicaltrials.gov/ct2/show/results/NCT00132691
Publication summary
2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20097325
Publication citations
-
Protocol
, Kempen JH, Altaweel MM, Holbrook JT, Jabs DA, Sugar EA, The multicenter uveitis steroid treatment trial: rationale, design, and baseline characteristics., Am. J. Ophthalmol., 2010, 149, 4, 550-561.e10, doi: 10.1016/j.ajo.2009.11.019.