UveitisPhase 4MUSTNCT00132691
Multicenter Uveitis Steroid Treatment (MUST) Trial
A Phase 4 study testing fluocinolone acetonide intraocular implant and oral corticosteroid with immunosuppressive agents as needed in people with Uveitis, run by JHSPH Center for Clinical Trials at 23 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Uveitis
- What is being tested?
- fluocinolone acetonide intraocular implant and oral corticosteroid with immunosuppressive agents as needed
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 23 sitesin 3 countries
- Study dates
- Sep 2005to Dec 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
23 sites in 3 countries.
23 sites in 3 countries
United States21 sites
Kellogg Eye Center, University of Michigan
Ann Arbor, Michigan, 48105
Emory University
Atlanta, Georgia, 30322
Wilmer Eye Institute, Johns Hopkins University
Baltimore, Maryland, 21287
National Eye Institute, NIH
Bethesda, Maryland, 20892
Massachusetts Eye Research & Surgery Institute
Cambridge, Massachusetts, 02142
Rush University Medical Center
Chicago, Illinois, 60612
University of Illinois at Chicago Eye Center
Chicago, Illinois, 60612
Texas Retina Associates
Dallas, Texas, 75231
Duke Eye Center, Duke University
Durham, North Carolina, 27710
Vitreoretinal Consultants
Houston, Texas, 77030
Jacobs Retina Center, UCSD
La Jolla, California, 92037
Doheny Eye Institute, USC
Los Angeles, California, 90033
Jules Stein Eye Institute, UCLA
Los Angeles, California, 90095
Anne Bates Leach Eye Hospital, University of Miami Miller School of Medicine
Miami, Florida, 33136
New York Eye and Ear Infirmary
New York, New York, 10016
Virginia Eye Consultants
Norfolk, Virginia, 23502
Scheie Eye Institute, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
John A. Moran Eye Center, University of Utah
Salt Lake City, Utah, 84132
Proctor Foundation, UCSF
San Francisco, California, 94143
Barnes Retina Institute
St Louis, Missouri, 63110
University of South Florida
Tampa, Florida, 33612
United Kingdom1 site
United Kingdom Institute of Ophthalmology
London, EC1V 9EL
About this study
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.
Read the detailed description
The MUST trial is a randomized controlled clinical trial comparing two treatments for patients with vision-threatening non-infectious intermediate uveitis, posterior uveitis, or panuveitis:
- local therapy with fluocinolone acetonide intraocular implant in affected eyes; versus
- standard therapy: systemic corticosteroid therapy supplemented, when indicated, by corticosteroid-sparing potent immuno-modulator therapy.
Study ophthalmologists, clinic coordinators, and patients will not be masked to treatment assignment. Masking will be applied to the determination of visual function at baseline, the six month visit, and thereafter . Patients will be followed until death, participant withdrawal, or a common study closeout. Patients will be seen at baseline, one month after randomization, three months after randomization, and every three months thereafter for data collection. Both ophthalmological and medical data will be collected to evaluate the outcomes of treatment of the uveitis, complications of the uveitis, and complications from therapy itself. Selected laboratory data related to the complications from systemic corticosteroid therapy will be collected.
The planned sample size of 250 patients, 125 per treatment group, is expected to give sufficient power to detect clinically important differences in visual acuity outcomes. Patients meeting the eligibility criteria detailed above will be enrolled at approximately 23 clinical centers in the United States, Australia and UK. Patients will be randomized on a 1:1 basis to one of the two treatment groups.
The MUST Research Group received additional funding at the completion of the MUST Trial to continue following patients enrolled in the study for an additional 7 years in the MUST Trial Follow-up Study (MUST FS). Since uveitis is often a chronic condition requiring long-term treatment, the objectives of the MUST FS are to evaluate outcomes of the two treatments over a longer period time. The outcomes specified for MUST FS are the same as those specified for the MUST Trial: visual acuity, ocular and systemic side effects of treatment, quality of life, and control of ocular inflammation. The primary analyses will be to compare outcomes between the original randomization groups, i.e., intention-to-treat. Secondary analyses will be based on treatment received. Study visits will be conducted every 6 months in MUST FS as opposed to every 3 months in the MUST Trial. Two analyses are planned for public release, one at 4.5 years and one after 7 years of follow-up. The Data Safety Monitoring Board reviewed and approved the analysis plan.
- Conditions
- Uveitis
- Being tested
- fluocinolone acetonide intraocular implant, oral corticosteroid with immunosuppressive agents as needed
- Keywords
- uveitis, non-infectious intermediate uveitis, non-infectious posterior uveitis, non-infectious panuveitis
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluocinolone acetonide intraocular implantDrug
Also called NDC 24208-416-01
RETISERT™ (fluocinolone acetonide intravitreal implant) 0.59 mg is a sterile implant designed to release fluocinolone acetonide locally to the posterior segment of the eye at a nominal initial rate of 0.6 μg/day, decreasing over the first month to a steady state between 0.3-0.4 μg/day over approximately 30 months.
oral corticosteroid with immunosuppressive agents as neededDrug
Also called Permitted immunosuppressive agents:, - Alkylating agents, cyclophosphamide (Cytoxan), chlorambacil
Prednisone
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Immunosuppressant medication implant Receives: Drug: fluocinolone acetonide intraocular implant |
| 2 | Active comparator | Systemic corticosteroids with immunosuppressant drugs as needed Receives: Drug: oral corticosteroid with immunosuppressive agents as needed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Best-corrected Visual Acuity (Change in the Numbers of Letters Read From a Standard ETDRS Eye Chart) From Baseline to 24 Months in Eyes With Uveitis
Best-corrected visual acuity was measured as the number of letters read from standard logarithmic visual acuity charts by study-certified examiners who were masked to treatment. Visual acuity was measured at all study visits. The primary outcome was eye-specific change in visual acuity from baseline to 2-year follow-up. Positive change values indicate improved vision while negative change values indicate vision has gotten worse. A change of 7.5 letters is considered clinically meaningful.
Measured: 24 months
Secondary outcomes (16)
Macular Edema
center point macular thickness >= 240 micrometers assessed on OCT (Stratus OCT-3 [Carl Zeiss Meditec, Dublin, CA]) as graded by Central Reading Center
Measured: 24 months
Uveitis Activity
Uveitis activity was determined by clinician assessment at each study visit. The study ophthalmologist evaluated each eye as active, inactive/never had uveitis or cannot assess.
Measured: 24 months
Intraocular Pressure - Incident IOP Greater Than or Equal to 30 mm Hg
Measured: 24 months
Intraocular Pressure - Incident IOP Greater Than or Equal to 24 mm Hg
Measured: 24 months
Intraocular Pressure - Incident IOP Elevation >= 10 mmHg Above Baseline
Measured: 24 months
Glaucoma - Incident
Glaucoma was diagnosed by a glaucoma specialist through review of visual fields, clinical data, and fundus images.
Measured: 24 months
Intraocular Pressure (IOP) - Incident Use of IOP-lowering Medical Therapy (Percentage of Eyes With Uveitis That Were Not Being Treated With IOP-lowering Medical Therapy at Baseline and Underwent IOP Lowering Therapy During the 24 Month Follow-up.
The percentage of subjects who used topical or systemic treatment for elevated IOP at any time during the 2 year follow-up and were not on IOP-lowering therapy at baseline is reported.
Measured: 24 months
Intraocular Pressure - IOP-lowering Surgery
Measured: 24 months
Cataract - Incident Cataract
Measured: 24 months
Change in Self-reported Vision-related Function as Measured by the National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ 25) Vision Targeted Composite Score From Baseline to 24 Months
The NEI-VFQ 25 measures the effect of visual disability/symptoms with generic health and task-oriented domains. The range for the composite score is 0 to 100; higher scores are associated with better visual function. A change of 4 to 6 points is considered to be a clinically meaningful difference.
Measured: 24 months
Change in SF-36 Mental Component Score From Baseline to 24 Months
Self-reported health related QoL was measured with the SF 36 survey. The mental component score for the SF 36 is a summary measure of mental health primarily based on the social functioning, role emotional, mental health and vitality domains. The score is scaled to a population norm with a mean of 50 and standard deviation of 10. Higher scores represent better outcomes. The mean change in scores between baseline and 24 months was calculated for each treatment group.
Measured: 24 months
Change in SF-36 Physical Component Score From Baseline to 24 Months
Self-reported health related QoL was measured with the SF 36 survey. The physical component score for the SF 36 is a summary measure of physical health primarily based on the physical functioning, role physical, bodily pain and general health domains of the survey. The score is scaled to a population norm with a mean of 50 and standard deviation of 10. Higher scores represent better outcomes. The mean change in scores between baseline and 24 months was calculated for each treatment group. A 3 to 5 point difference is considered to be clinically meaningful.
Measured: 24 months
Hyperlipidemia - Incident
LDL greater than or equal to 160 mg/mL
Measured: 24 months
Hypertension Diagnosis Requiring Treatment
Measured: 24 months
Diabetes Mellitus
Measured: 24 months
Mortality
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startSep 2005
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- JHSPH Center for Clinical Trials
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Douglas Jabs, MD, MBA, Study chair, Icahn School of Medicine at Mount SinaiJohn Kempen, MD, PhD, Study chair, Scheie Eye Center, University of PennsylvaniaJanet T Holbrook, PhD, MPH, Study director, Director of Coordinating Cener, Johns Hopkins Bloomberg School of Public HealthMichael Altaweel, MD, Study director, Director of Fundus Photography Reading Center, University of Wisconsin at Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132691
- Sponsor's protocol ID
- NEI-106
- Other IDs
- U10EY014660, 1U10EY014660-2, ISRCTN15396562
- Acronym
- MUST
- Status last verified
- Oct 2016
- First submitted
- 19 Aug 2005
- Last updated
- 25 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group; Kempen JH, Altaweel MM, Holbrook JT, Jabs DA, Louis TA, Sugar EA, Thorne JE. Randomized comparison of systemic anti-inflammatory therapy versus fluocinolone acetonide implant for intermediate, posterior, and panuveitis: the multicenter uveitis steroid treatment trial. Ophthalmology. 2011 Oct;118(10):1916-26. doi: 10.1016/j.ophtha.2011.07.027. Epub 2011 Aug 15.
PubMed 21840602Tomkins-Netzer O, Lightman SL, Burke AE, Sugar EA, Lim LL, Jaffe GJ, Altaweel MM, Kempen JH, Holbrook JT, Jabs DA; Multicenter Steroid Treatment Trial and Follow-up Study Research Group. Seven-Year Outcomes of Uveitic Macular Edema: The Multicenter Uveitis Steroid Treatment Trial and Follow-up Study Results. Ophthalmology. 2021 May;128(5):719-728. doi: 10.1016/j.ophtha.2020.08.035. Epub 2020 Sep 10.
PubMed 32918964Writing Committee for the Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study Research Group; Kempen JH, Altaweel MM, Holbrook JT, Sugar EA, Thorne JE, Jabs DA. Association Between Long-Lasting Intravitreous Fluocinolone Acetonide Implant vs Systemic Anti-inflammatory Therapy and Visual Acuity at 7 Years Among Patients With Intermediate, Posterior, or Panuveitis. JAMA. 2017 May 16;317(19):1993-2005. doi: 10.1001/jama.2017.5103.
PubMed 28477440Yu T, Holbrook JT, Thorne JE, Puhan MA. Using a patient-centered approach to benefit-harm assessment in treatment decision-making: a case study in uveitis. Pharmacoepidemiol Drug Saf. 2016 Apr;25(4):363-71. doi: 10.1002/pds.3959. Epub 2016 Jan 22.
PubMed 26798977Yu T, Holbrook JT, Thorne JE, Flynn TN, Van Natta ML, Puhan MA. Outcome Preferences in Patients With Noninfectious Uveitis: Results of a Best-Worst Scaling Study. Invest Ophthalmol Vis Sci. 2015 Oct;56(11):6864-72. doi: 10.1167/iovs.15-16705.
PubMed 26501236Drye LT, Casper AS, Sternberg AL, Holbrook JT, Jenkins G, Meinert CL. The transitioning from trials to extended follow-up studies. Clin Trials. 2014 Dec;11(6):635-47. doi: 10.1177/1740774514547396. Epub 2014 Aug 12.
PubMed 25115882Domalpally A, Altaweel MM, Kempen JH, Myers D, Davis JL, Foster CS, Latkany P, Srivastava SK, Stawell RJ, Holbrook JT; MUST Trial Research Group. Optical coherence tomography evaluation in the Multicenter Uveitis Steroid Treatment (MUST) trial. Ocul Immunol Inflamm. 2012 Dec;20(6):443-7. doi: 10.3109/09273948.2012.719258. Epub 2012 Nov 19.
PubMed 23163490Sen HN, Drye LT, Goldstein DA, Larson TA, Merrill PT, Pavan PR, Sheppard JD, Burke A, Srivastava SK, Jabs DA; Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group. Hypotony in patients with uveitis: The Multicenter Uveitis Steroid Treatment (MUST) Trial. Ocul Immunol Inflamm. 2012 Apr;20(2):104-12. doi: 10.3109/09273948.2011.647228.
PubMed 22409563Frick KD, Drye LT, Kempen JH, Dunn JP, Holland GN, Latkany P, Rao NA, Sen HN, Sugar EA, Thorne JE, Wang RC, Holbrook JT; Multicenter Uveitis Steroid Treatment-MUST Trial Research Group. Associations among visual acuity and vision- and health-related quality of life among patients in the multicenter uveitis steroid treatment trial. Invest Ophthalmol Vis Sci. 2012 Mar 9;53(3):1169-76. doi: 10.1167/iovs.11-8259. Print 2012 Mar.
PubMed 22247489Sugar EA, Jabs DA, Altaweel MM, Lightman S, Acharya N, Vitale AT, Thorne JE; Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group. Identifying a clinically meaningful threshold for change in uveitic macular edema evaluated by optical coherence tomography. Am J Ophthalmol. 2011 Dec;152(6):1044-1052.e5. doi: 10.1016/j.ajo.2011.05.028. Epub 2011 Sep 8.
PubMed 21861971Madow B, Galor A, Feuer WJ, Altaweel MM, Davis JL. Validation of a photographic vitreous haze grading technique for clinical trials in uveitis. Am J Ophthalmol. 2011 Aug;152(2):170-176.e1. doi: 10.1016/j.ajo.2011.01.058. Epub 2011 Jun 8.
PubMed 21652026
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Uveitis Steroid Treatment (MUST) Trial
- ClinicalTrials.gov ID
- NCT00132691
- Acronym / sponsor ID
- MUST / NEI-106
- Conditions
- Uveitis
- Keywords
- uveitis, non-infectious intermediate uveitis, non-infectious posterior uveitis, non-infectious panuveitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- JHSPH Center for Clinical TrialsUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Sep 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 22 Aug 2005 (estimated)
- Results
- Posted 30 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The MUST trial is a randomized controlled clinical trial comparing two treatments for patients with vision-threatening non-infectious intermediate uveitis, posterior uveitis, or panuveitis:
- local therapy with fluocinolone acetonide intraocular implant in affected eyes; versus
- standard therapy: systemic corticosteroid therapy supplemented, when indicated, by corticosteroid-sparing potent immuno-modulator therapy.
Study ophthalmologists, clinic coordinators, and patients will not be masked to treatment assignment. Masking will be applied to the determination of visual function at baseline, the six month visit, and thereafter . Patients will be followed until death, participant withdrawal, or a common study closeout. Patients will be seen at baseline, one month after randomization, three months after randomization, and every three months thereafter for data collection. Both ophthalmological and medical data will be collected to evaluate the outcomes of treatment of the uveitis, complications of the uveitis, and complications from therapy itself. Selected laboratory data related to the complications from systemic corticosteroid therapy will be collected.
The planned sample size of 250 patients, 125 per treatment group, is expected to give sufficient power to detect clinically important differences in visual acuity outcomes. Patients meeting the eligibility criteria detailed above will be enrolled at approximately 23 clinical centers in the United States, Australia and UK. Patients will be randomized on a 1:1 basis to one of the two treatment groups.
The MUST Research Group received additional funding at the completion of the MUST Trial to continue following patients enrolled in the study for an additional 7 years in the MUST Trial Follow-up Study (MUST FS). Since uveitis is often a chronic condition requiring long-term treatment, the objectives of the MUST FS are to evaluate outcomes of the two treatments over a longer period time. The outcomes specified for MUST FS are the same as those specified for the MUST Trial: visual acuity, ocular and systemic side effects of treatment, quality of life, and control of ocular inflammation. The primary analyses will be to compare outcomes between the original randomization groups, i.e., intention-to-treat. Secondary analyses will be based on treatment received. Study visits will be conducted every 6 months in MUST FS as opposed to every 3 months in the MUST Trial. Two analyses are planned for public release, one at 4.5 years and one after 7 years of follow-up. The Data Safety Monitoring Board reviewed and approved the analysis plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: fluocinolone acetonide intraocular implantImmunosuppressant medication implant |
| 2 | Active comparator | Drug: oral corticosteroid with immunosuppressive agents as neededSystemic corticosteroids with immunosuppressant drugs as needed |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluocinolone acetonide intraocular implantAlso: NDC 24208-416-01RETISERT™ (fluocinolone acetonide intravitreal implant) 0.59 mg is a sterile implant designed to release fluocinolone acetonide locally to the posterior segment of the eye at a nominal initial rate of 0.6 μg/day, decreasing over the first month to a steady state between 0.3-0.4 μg/day over approximately 30 months. | Drug | 1 |
| oral corticosteroid with immunosuppressive agents as neededAlso: Permitted immunosuppressive agents:, - Alkylating agents, cyclophosphamide (Cytoxan), chlorambacilPrednisone | Drug | 2 |
Primary outcome
Change in Best-corrected Visual Acuity (Change in the Numbers of Letters Read From a Standard ETDRS Eye Chart) From Baseline to 24 Months in Eyes With Uveitis
Time frame: 24 months
Best-corrected visual acuity was measured as the number of letters read from standard logarithmic visual acuity charts by study-certified examiners who were masked to treatment. Visual acuity was measured at all study visits. The primary outcome was eye-specific change in visual acuity from baseline to 2-year follow-up. Positive change values indicate improved vision while negative change values indicate vision has gotten worse. A change of 7.5 letters is considered clinically meaningful.
16 secondary outcomes
Macular Edema
Time frame: 24 months
Uveitis Activity
Time frame: 24 months
Intraocular Pressure - Incident IOP Greater Than or Equal to 30 mm Hg
Time frame: 24 months
Intraocular Pressure - Incident IOP Greater Than or Equal to 24 mm Hg
Time frame: 24 months
Intraocular Pressure - Incident IOP Elevation >= 10 mmHg Above Baseline
Time frame: 24 months
Glaucoma - Incident
Time frame: 24 months
Intraocular Pressure (IOP) - Incident Use of IOP-lowering Medical Therapy (Percentage of Eyes With Uveitis That Were Not Being Treated With IOP-lowering Medical Therapy at Baseline and Underwent IOP Lowering Therapy During the 24 Month Follow-up.
Time frame: 24 months
Intraocular Pressure - IOP-lowering Surgery
Time frame: 24 months
Cataract - Incident Cataract
Time frame: 24 months
Change in Self-reported Vision-related Function as Measured by the National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ 25) Vision Targeted Composite Score From Baseline to 24 Months
Time frame: 24 months
Change in SF-36 Mental Component Score From Baseline to 24 Months
Time frame: 24 months
Change in SF-36 Physical Component Score From Baseline to 24 Months
Time frame: 24 months
Hyperlipidemia - Incident
Time frame: 24 months
Hypertension Diagnosis Requiring Treatment
Time frame: 24 months
Diabetes Mellitus
Time frame: 24 months
Mortality
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21840602Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group; Kempen JH, Altaweel MM, Holbrook JT, Jabs DA, Louis TA, Sugar EA, Thorne JE. Randomized comparison of systemic anti-inflammatory therapy versus fluocinolone acetonide implant for intermediate, posterior, and panuveitis: the multicenter uveitis steroid treatment trial. Ophthalmology. 2011 Oct;118(10):1916-26. doi: 10.1016/j.ophtha.2011.07.027. Epub 2011 Aug 15.
- Derived from this study: PubMed 32918964Tomkins-Netzer O, Lightman SL, Burke AE, Sugar EA, Lim LL, Jaffe GJ, Altaweel MM, Kempen JH, Holbrook JT, Jabs DA; Multicenter Steroid Treatment Trial and Follow-up Study Research Group. Seven-Year Outcomes of Uveitic Macular Edema: The Multicenter Uveitis Steroid Treatment Trial and Follow-up Study Results. Ophthalmology. 2021 May;128(5):719-728. doi: 10.1016/j.ophtha.2020.08.035. Epub 2020 Sep 10.
- Derived from this study: PubMed 28477440Writing Committee for the Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study Research Group; Kempen JH, Altaweel MM, Holbrook JT, Sugar EA, Thorne JE, Jabs DA. Association Between Long-Lasting Intravitreous Fluocinolone Acetonide Implant vs Systemic Anti-inflammatory Therapy and Visual Acuity at 7 Years Among Patients With Intermediate, Posterior, or Panuveitis. JAMA. 2017 May 16;317(19):1993-2005. doi: 10.1001/jama.2017.5103.
- Derived from this study: PubMed 26798977Yu T, Holbrook JT, Thorne JE, Puhan MA. Using a patient-centered approach to benefit-harm assessment in treatment decision-making: a case study in uveitis. Pharmacoepidemiol Drug Saf. 2016 Apr;25(4):363-71. doi: 10.1002/pds.3959. Epub 2016 Jan 22.
- Derived from this study: PubMed 26501236Yu T, Holbrook JT, Thorne JE, Flynn TN, Van Natta ML, Puhan MA. Outcome Preferences in Patients With Noninfectious Uveitis: Results of a Best-Worst Scaling Study. Invest Ophthalmol Vis Sci. 2015 Oct;56(11):6864-72. doi: 10.1167/iovs.15-16705.
- Derived from this study: PubMed 25115882Drye LT, Casper AS, Sternberg AL, Holbrook JT, Jenkins G, Meinert CL. The transitioning from trials to extended follow-up studies. Clin Trials. 2014 Dec;11(6):635-47. doi: 10.1177/1740774514547396. Epub 2014 Aug 12.
- Derived from this study: PubMed 23163490Domalpally A, Altaweel MM, Kempen JH, Myers D, Davis JL, Foster CS, Latkany P, Srivastava SK, Stawell RJ, Holbrook JT; MUST Trial Research Group. Optical coherence tomography evaluation in the Multicenter Uveitis Steroid Treatment (MUST) trial. Ocul Immunol Inflamm. 2012 Dec;20(6):443-7. doi: 10.3109/09273948.2012.719258. Epub 2012 Nov 19.
- Derived from this study: PubMed 22409563Sen HN, Drye LT, Goldstein DA, Larson TA, Merrill PT, Pavan PR, Sheppard JD, Burke A, Srivastava SK, Jabs DA; Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group. Hypotony in patients with uveitis: The Multicenter Uveitis Steroid Treatment (MUST) Trial. Ocul Immunol Inflamm. 2012 Apr;20(2):104-12. doi: 10.3109/09273948.2011.647228.
- Derived from this study: PubMed 22247489Frick KD, Drye LT, Kempen JH, Dunn JP, Holland GN, Latkany P, Rao NA, Sen HN, Sugar EA, Thorne JE, Wang RC, Holbrook JT; Multicenter Uveitis Steroid Treatment-MUST Trial Research Group. Associations among visual acuity and vision- and health-related quality of life among patients in the multicenter uveitis steroid treatment trial. Invest Ophthalmol Vis Sci. 2012 Mar 9;53(3):1169-76. doi: 10.1167/iovs.11-8259. Print 2012 Mar.
- Derived from this study: PubMed 21861971Sugar EA, Jabs DA, Altaweel MM, Lightman S, Acharya N, Vitale AT, Thorne JE; Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group. Identifying a clinically meaningful threshold for change in uveitic macular edema evaluated by optical coherence tomography. Am J Ophthalmol. 2011 Dec;152(6):1044-1052.e5. doi: 10.1016/j.ajo.2011.05.028. Epub 2011 Sep 8.
- Derived from this study: PubMed 21652026Madow B, Galor A, Feuer WJ, Altaweel MM, Davis JL. Validation of a photographic vitreous haze grading technique for clinical trials in uveitis. Am J Ophthalmol. 2011 Aug;152(2):170-176.e1. doi: 10.1016/j.ajo.2011.01.058. Epub 2011 Jun 8.
- MUST, JHU, Center for Clinical TrialsLink provided by the sponsor.
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Serum EBI-3 Protein Levels in Behçet's Disease
Behçet Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Jabs, MD, MBA study chair
Icahn School of Medicine at Mount Sinai
John Kempen, MD, PhD study chair
Scheie Eye Center, University of Pennsylvania
Janet T Holbrook, PhD, MPH study director
Director of Coordinating Cener, Johns Hopkins Bloomberg School of Public Health
23 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fluocinolone acetonide intraocular implant and oral corticosteroid with immunosuppressive agents as needed in people with Uveitis, run by JHSPH Center for Clinical Trials at 23 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Australia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Best-corrected Visual Acuity (Change in the Numbers of Letters Read From a Standard ETDRS Eye Chart) From Baseline to 24 Months in Eyes With Uveitis (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00132691, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2016.