Condition category
Eye Diseases
Date applied
13/08/2007
Date assigned
17/08/2007
Last edited
23/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.musttrial.org

Contact information

Type

Scientific

Primary contact

Dr Douglas Jabs

ORCID ID

Contact details

Mount Sinai School of Medicine
Department of Ophthalmology
One Gustave L. Levy Place
Box 1183
New York
10029-6584
United States of America

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

  1. 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.

Additional files

Editorial Notes

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.