Multicenter Uveitis Steroid Treatment Trial
| ISRCTN | ISRCTN15396562 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15396562 |
| ClinicalTrials.gov number | NCT00132691 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/08/2007
- Registration date
- 17/08/2007
- Last edited
- 26/11/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Douglas Jabs
Scientific
Scientific
Mount Sinai School of Medicine
Department of Ophthalmology
One Gustave L. Levy Place
Box 1183
New York
10029-6584
United States of America
Study information
| Study design | Open-label parallel-assignment randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Multicenter Uveitis Steroid Treatment Trial |
| Study acronym | MUST |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Fluocinolone acetonide, corticosteroid, immunosuppressive agents |
| Primary outcome measure | 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 study start date | 01/12/2005 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 250 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2005 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- Australia
- United Kingdom
- United States of America
Study participating centre
Mount Sinai School of Medicine
New York
10029-6584
United States of America
10029-6584
United States of America
Sponsor information
The Multicenter Uveitis Steroid Treatment Trial (MUST) Coordinating Center (USA)
Other
Other
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
Funders
Funder type
Government
National Eye Institute
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Instituto Nacional del Ojo, NIH/National Eye Institute, NEI
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Protocol article | protocol | 01/04/2010 | Yes | No | |
| Results article | results | 01/11/2015 | Yes | No |
Editorial Notes
26/11/2018: Publication reference added.
Please note that the following changes have been made to this trial record as of 26/11/2008:
1. The overall trial end date has been extended from 31/03/2009 to 31/12/2011
2. The target number of participants has been changed from 400 to 250
Please note that recruitment has been completed in November 2008, and the trial is in the follow-up phase as of 26/11/2008.
Please note that as of 06/04/10, details of the most recent ethics approval have been added to the ethics field.
