| ID | Type | Description | Link |
|---|---|---|---|
| U10EY014660 | U.S. NIH Grant/Contract | View source | |
| 1U10EY014660-2 | |||
| ISRCTN15396562 |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Immunosuppressant medication implant |
|
| 2 | Active Comparator | Systemic corticosteroids with immunosuppressant drugs as needed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluocinolone acetonide intraocular implant | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 months |
| Uveitis Activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Jabs, MD, MBA | Icahn School of Medicine at Mount Sinai | Study Chair |
| John Kempen, MD, PhD | Scheie Eye Center, University of Pennsylvania | Study Chair |
| Janet T Holbrook, PhD, MPH | Director of Coordinating Cener, Johns Hopkins Bloomberg School of Public Health | Study Director |
| Michael Altaweel, MD | Director of Fundus Photography Reading Center, University of Wisconsin at Madison | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacobs Retina Center, UCSD | La Jolla | California | 92037 | United States | ||
| Doheny Eye Institute, USC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21840602 | Result | 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. | |
| 32918964 | Derived |
| Label | URL |
|---|---|
| MUST, JHU, Center for Clinical Trials | View source |
Not provided
579 patients were assessed for initial eligibility (e.g. through chart review). Patients who were potentially eligible and interested in joining the trial signed an informed consent and underwent a baseline visit to confirm eligibility. Eligible patients (255) were randomly assigned to systemic treatment or implant treatment.
Eligible patients were enrolled at 23 uveitis centers in the US, the United Kingdom and Australia from 6 December 2005 to 9 December 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Flucinolone Acetonide Intraocular Implant | Local therapy with fluocinolone acetonide 0.59 mg implant (Retisert; Bausch & Lomb Inc.) in each eye with uveitis of sufficient severity to justify treatment with systemic corticosteroids |
| FG001 | Standard Systemic Treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| oral corticosteroid with immunosuppressive agents as needed | Drug | Prednisone |
|
|
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.
| 24 months |
| Intraocular Pressure - Incident IOP Greater Than or Equal to 30 mm Hg | 24 months |
| Intraocular Pressure - Incident IOP Greater Than or Equal to 24 mm Hg | 24 months |
| Intraocular Pressure - Incident IOP Elevation >= 10 mmHg Above Baseline | 24 months |
| Glaucoma - Incident | Glaucoma was diagnosed by a glaucoma specialist through review of visual fields, clinical data, and fundus images. | 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. | 24 months |
| Intraocular Pressure - IOP-lowering Surgery | 24 months |
| Cataract - Incident Cataract | 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. | 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. | 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. | 24 months |
| Hyperlipidemia - Incident | LDL greater than or equal to 160 mg/mL | 24 months |
| Hypertension Diagnosis Requiring Treatment | 24 months |
| Diabetes Mellitus | 24 months |
| Mortality | 24 months |
| Los Angeles |
| California |
| 90033 |
| United States |
| Jules Stein Eye Institute, UCLA | Los Angeles | California | 90095 | United States |
| Proctor Foundation, UCSF | San Francisco | California | 94143 | United States |
| Anne Bates Leach Eye Hospital, University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
| University of South Florida | Tampa | Florida | 33612 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Illinois at Chicago Eye Center | Chicago | Illinois | 60612 | United States |
| Wilmer Eye Institute, Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| National Eye Institute, NIH | Bethesda | Maryland | 20892 | United States |
| Massachusetts Eye Research & Surgery Institute | Cambridge | Massachusetts | 02142 | United States |
| Kellogg Eye Center, University of Michigan | Ann Arbor | Michigan | 48105 | United States |
| Barnes Retina Institute | St Louis | Missouri | 63110 | United States |
| New York Eye and Ear Infirmary | New York | New York | 10016 | United States |
| Duke Eye Center, Duke University | Durham | North Carolina | 27710 | United States |
| Scheie Eye Institute, University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Texas Retina Associates | Dallas | Texas | 75231 | United States |
| Vitreoretinal Consultants | Houston | Texas | 77030 | United States |
| John A. Moran Eye Center, University of Utah | Salt Lake City | Utah | 84132 | United States |
| Virginia Eye Consultants | Norfolk | Virginia | 23502 | United States |
| Royal Victoria Eye & Ear Hospital | East Melbourne | Australia |
| United Kingdom Institute of Ophthalmology | London | EC1V 9EL | United Kingdom |
| Tomkins-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. |
| 28477440 | Derived | Writing 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. |
| 26798977 | Derived | Yu 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. |
| 26501236 | Derived | Yu 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. |
| 25115882 | Derived | Drye 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. |
| 23163490 | Derived | Domalpally 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. |
| 22409563 | Derived | Sen 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. |
| 22247489 | Derived | Frick 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. |
| 21861971 | Derived | Sugar 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. |
| 21652026 | Derived | Madow 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. |
Systemic corticosteroid therapy with immunosuppression as indicated |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Flucinolone Acetonide Intraocular Implant | Local therapy with fluocinolone acetonide 0.59 mg implant (Retisert; Bausch & Lomb Inc.) in each eye with uveitis of sufficient severity to justify treatment with systemic corticosteroids |
| BG001 | Standard Systemic Treatment | Systemic corticosteroid therapy with immunosuppression as indicated |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Bilateral uveitis | Number | participants |
| ||||||||||||||||
| Site of uveitis | Number | participants |
| ||||||||||||||||
| Associated systemic inflammatory disease | Number | participants |
| ||||||||||||||||
| Visual acuity 20/40 or better | Number | eyes |
| ||||||||||||||||
| Active uveitis | Number | eyes |
| ||||||||||||||||
| Visual acuity 20/200 or worse | Number | eyes |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The primary analysis was an intention-to-treat analysis; analysis was conducted "as randomized". Data from the 255 randomized participants were used in the analytic model. 232 of the 255 completed the 2 year outcome visit. | Posted | Mean | Standard Error | letters | 24 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | All eyes with uveitis were included in the analysis (245 eyes of the 129 participants randomized to implant therapy and 234 eyes of the 126 participants randomized to systemic therapy).. | Posted | Number | 95% Confidence Interval | percentage of eyes with uveitis | 24 months | eyes with macular edema | Participants |
|
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| Secondary | 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. | All eyes with uveitis were included in the analysis (245 eyes of the 129 participants randomized to implant therapy and 234 eyes of the 126 participants randomized to systemic therapy). | Posted | Number | 95% Confidence Interval | percentage of eyes with uveitis | 24 months | eyes with uveitis | Participants |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Intraocular Pressure - Incident IOP Greater Than or Equal to 30 mm Hg | Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set. | Posted | Number | 95% Confidence Interval | percentage of eyes with uveitis at risk | 24 months | eyes with uveitis | Participants |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Intraocular Pressure - Incident IOP Greater Than or Equal to 24 mm Hg | Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set. | Posted | Number | 95% Confidence Interval | percentage of eyes with uveitis at risk | 24 months | eyes with uveitis | Participants |
|
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| Secondary | Intraocular Pressure - Incident IOP Elevation >= 10 mmHg Above Baseline | Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set. | Posted | Number | 95% Confidence Interval | percentage of eyes with uveitis at risk | 24 months | eyes with uveitis | Participants |
|
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| Secondary | Glaucoma - Incident | Glaucoma was diagnosed by a glaucoma specialist through review of visual fields, clinical data, and fundus images. | Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set. | Posted | Number | 95% Confidence Interval | percentage of eyes with uveitis at risk | 24 months | eyes with uveitis | Participants |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set. | Posted | Number | 95% Confidence Interval | percentage of eyes with uveitis at risk | 24 months | eyes | Participants |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Intraocular Pressure - IOP-lowering Surgery | Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set. | Posted | Number | 95% Confidence Interval | percentage of eyes with uveitis at risk | 24 months | eyes with uveitis | Participants |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cataract - Incident Cataract | Eyes with uveitis, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set. | Posted | Number | 95% Confidence Interval | percentage of eyes with uveitis at risk | 24 months | eyes with uveitis | Participants |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Error | units on a scale (composite score) | 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Error | units on a scale | 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Error | units on a scale | 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hyperlipidemia - Incident | LDL greater than or equal to 160 mg/mL | Number of participants at risk were included in the analysis | Posted | Number | 95% Confidence Interval | percentage of participants at risk | 24 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hypertension Diagnosis Requiring Treatment | Participants with prevalent complications or missing data at enrollment were excluded from the risk set. | Posted | Number | 95% Confidence Interval | percentage of participants | 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Diabetes Mellitus | Participants with prevalent complications or missing data at enrollment were excluded from the risk set. | Posted | Number | 95% Confidence Interval | percentage of participants | 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mortality | Posted | Number | 95% Confidence Interval | percentage of participants | 24 months |
|
|
2 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Flucinolone Acetonide Implant | Participants randomized to receive implant therapy. | 75 | 129 | 113 | 129 | ||
| EG001 | Systemic Therapy | Participants randomized to receive systemic therapy. | 47 | 126 | 113 | 126 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endophthalmitis | Eye disorders | Non-systematic Assessment |
| ||
| Glaucoma | Eye disorders | Non-systematic Assessment |
| ||
| Hypotony | Eye disorders | Non-systematic Assessment |
| ||
| Ocular Hypertension | Eye disorders | Non-systematic Assessment |
| ||
| Retinal Detachment | Eye disorders | Non-systematic Assessment |
| ||
| Vitreous Hemorrhage | Eye disorders | Non-systematic Assessment |
| ||
| Bleb revision | Eye disorders | Non-systematic Assessment |
| ||
| Complication of Kenalog injection | Eye disorders | Non-systematic Assessment |
| ||
| Enucleation | Eye disorders | Non-systematic Assessment |
| ||
| Hospitalization for cataract surgery | Eye disorders | Non-systematic Assessment |
| ||
| Retisert wound dehiscence | Eye disorders | Non-systematic Assessment |
| ||
| Choroidal neovascularization | Eye disorders | Non-systematic Assessment |
| ||
| Hyphema | Eye disorders | Non-systematic Assessment |
| ||
| Exposed suture | Eye disorders | Non-systematic Assessment |
| ||
| Surgery to reposition shunt | Eye disorders | Non-systematic Assessment |
| ||
| Iris bombe | Eye disorders | Non-systematic Assessment |
| ||
| Exposed Ahmed valve | Eye disorders | Non-systematic Assessment |
| ||
| Orbital cellulitis | Eye disorders | Non-systematic Assessment |
| ||
| Revision of Ahmed valve | Eye disorders | Non-systematic Assessment |
| ||
| Abnormal ERG | Eye disorders | Non-systematic Assessment |
| ||
| Hospitalization for observation while on prednisone | Psychiatric disorders | Non-systematic Assessment |
| ||
| Anterior cervical dissection, fusion | Nervous system disorders | Non-systematic Assessment |
| ||
| Diarrhea, dehydration | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Ileostomy takedown | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Perforated viscus lung cancer | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pericardial drain placement | Cardiac disorders | Non-systematic Assessment |
| ||
| Hysterectomy | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Kidney stones | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Hip replacement | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Precancerous cells right breast | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Prolonged hospitalization stay due to reaction | General disorders | Non-systematic Assessment |
| ||
| Shoulder surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Total thyroidectomy | Endocrine disorders | Non-systematic Assessment |
| ||
| Abdominal pain | General disorders | Non-systematic Assessment |
| ||
| Arthrosis due to aseptic necrosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Dislocation of hip | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Exacerbation of intestinal fissure | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Flu-like reaction to Avonex | General disorders | Non-systematic Assessment |
| ||
| Gall bladder surgery | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Hypertension | Cardiac disorders | Non-systematic Assessment |
| ||
| Hemmorhagic cystitis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Hydronephrosis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Hospitalization | General disorders | Non-systematic Assessment |
| ||
| Hospitalization for post-surgical observation of pharyngeal papilloma biopsy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Hip pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Torn medial meniscus | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Neuro Bechet's disease | Immune system disorders | Non-systematic Assessment |
| ||
| Cervical dysplasia | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Psychotic episode | Psychiatric disorders | Non-systematic Assessment |
| ||
| Abnormal laboratory value | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Miscarriage | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Non-melanoma skin cancer | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Cardiovascular | Cardiac disorders | Non-systematic Assessment |
| ||
| Thrombosis | Vascular disorders | Non-systematic Assessment |
| ||
| Headache due to hypertension | General disorders | Non-systematic Assessment |
| ||
| Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Chest pain | Investigations | Non-systematic Assessment |
| ||
| Gastrointestinal | Gastrointestinal disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia (fasting) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycemia (casual) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Triglyceride (high) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| SGOT (AST) or SGPT (ALT) | Hepatobiliary disorders | Systematic Assessment |
| ||
| BUN | Renal and urinary disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Mood | Psychiatric disorders | Non-systematic Assessment |
| ||
| Headache | General disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Hypertension (systolic) | Cardiac disorders | Systematic Assessment |
| ||
| Hypertension (diastolic) | Cardiac disorders | Systematic Assessment |
| ||
| Allergic reaction | Immune system disorders | Non-systematic Assessment |
| ||
| Osteoporosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Infection | General disorders | Non-systematic Assessment |
| ||
| Ocular hypertension | Eye disorders | Systematic Assessment |
| ||
| Glaucoma | Eye disorders | Systematic Assessment |
| ||
| Hypotony | Eye disorders | Systematic Assessment |
| ||
| Cataract | Eye disorders | Systematic Assessment |
| ||
| Vitreous hemorrhage | Eye disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John H. Kempen, MD, PhD, MUST Trial Vice-Chairman | Center for Presventive Ophthalmology and Biostatistics, Department of Ophthalmology, University of Pennsylvania | 215-615-1500 | john.kempen@uphs.upenn.edu |
| ID | Term |
|---|---|
| D014605 | Uveitis |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D007166 | Immunosuppressive Agents |
| D006301 | Health Services Needs and Demand |
| D000477 | Alkylating Agents |
| D003520 | Cyclophosphamide |
| D001379 | Azathioprine |
| D002699 | Chlorambucil |
| D008727 | Methotrexate |
| D009173 | Mycophenolic Acid |
| D016572 | Cyclosporine |
| D016559 | Tacrolimus |
| D001688 | Biological Products |
| D000069285 | Infliximab |
| D000077561 | Daclizumab |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D007155 | Immunologic Factors |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D006302 | Health Services Research |
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D003695 | Delivery of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D009676 | Noxae |
| D004786 | Toxic Actions |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D015122 | Mercaptopurine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D018942 | Macrolides |
| D007783 | Lactones |
| D045424 | Complex Mixtures |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D061067 | Antibodies, Monoclonal, Humanized |
Not provided
Not provided
| Male |
|
| Hispanic |
|
| Black |
|
| Other |
|
| Australia |
|
| United Kingdom |
|
| Posterior or Panuveitis |
|
| no |
|
| No |
| Superiority or Other |
| eyes with macular edema |
|
|
|
| eyes with uveitis |
|
|
|
| eyes with uveitis |
|
|
|
| eyes with uveitis |
|
|
|
| eyes with uveitis |
|
|
|
| eyes with uveitis |
|
|
|
| eyes |
|
|
|
| eyes with uveitis |
|
|
|
| eyes with uveitis |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|