Multicenter Uveitis Steroid Treatment Trial
| ISRCTN | ISRCTN15396562 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15396562 |
| ClinicalTrials.gov (NCT) | NCT00132691 |
| Protocol serial number | N/A |
| Sponsor | The Multicenter Uveitis Steroid Treatment Trial (MUST) Coordinating Center (USA) |
| Funder | National Eye Institute |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
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
| Primary study design | Interventional |
|---|---|
| Study design | Open-label parallel-assignment randomised controlled trial |
| Secondary study design | Randomised parallel trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Fluocinolone acetonide, corticosteroid, immunosuppressive agents |
| Primary outcome measure(s) |
Change in best-corrected visual acuity as measured by a logarithmic chart (measured at every study visit). Total duration of follow-up: 2 years |
| Key secondary outcome measure(s) |
1. Occurrence of ocular complications |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- Australia
- United States of America
Study participating centre
10029-6584
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2015 | Yes | No | |
| Protocol article | protocol | 01/04/2010 | Yes | No | |
| Basic results | No | No | |||
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
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.
