Trial · NCT00132691
Multicenter Uveitis Steroid Treatment (MUST) Trial
NCT00132691, Phase 4, Completed, JHSPH Center for Clinical Trials; results first posted 2012-07-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Multicenter Uveitis Steroid Treatment (MUST) Trial. Trials, record NCT00132691. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00132691
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multicenter Uveitis Steroid Treatment (MUST) Trial
- NCT number
- NCT00132691
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 255 participants, actual
- Lead sponsor
- JHSPH Center for Clinical Trials
- Conditions
- Uveitis
- Interventions
- fluocinolone acetonide intraocular implant, oral corticosteroid with immunosuppressive agents as needed
- First posted
- 2005-08-22
- Last updated
- 2016-11-25
- Other registries' IDs
- isrctn:ISRCTN15396562
- Results first posted
- 2012-07-30
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 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. |
| Secondary | Macular Edema | 24 months | center point macular thickness \>= 240 micrometers assessed on OCT (Stratus OCT-3 \[Carl Zeiss Meditec, Dublin, CA\]) as graded by Central Reading Center |
| Secondary | Uveitis Activity | 24 months | 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. |
| Secondary | Intraocular Pressure - Incident IOP Greater Than or Equal to 30 mm Hg | 24 months | |
| Secondary | Intraocular Pressure - Incident IOP Greater Than or Equal to 24 mm Hg | 24 months | |
| Secondary | Intraocular Pressure - Incident IOP Elevation >= 10 mmHg Above Baseline | 24 months | |
| Secondary | Glaucoma - Incident | 24 months | Glaucoma was diagnosed by a glaucoma specialist through review of visual fields, clinical data, and fundus images. |
| 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. | 24 months | 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. |
| Secondary | Intraocular Pressure - IOP-lowering Surgery | 24 months | |
| Secondary | Cataract - Incident Cataract | 24 months |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | 24 months | 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. | letters | MEAN |
| SECONDARY | Macular Edema | 24 months | 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).. | percentage of eyes with uveitis | NUMBER |
| SECONDARY | Uveitis Activity | 24 months | 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). | percentage of eyes with uveitis | NUMBER |
| SECONDARY | Intraocular Pressure - Incident IOP Greater Than or Equal to 30 mm Hg | 24 months | Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set. | percentage of eyes with uveitis at risk | NUMBER |
| SECONDARY | Intraocular Pressure - Incident IOP Greater Than or Equal to 24 mm Hg | 24 months | Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set. | percentage of eyes with uveitis at risk | NUMBER |
| SECONDARY | Intraocular Pressure - Incident IOP Elevation >= 10 mmHg Above Baseline | 24 months | Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set. | percentage of eyes with uveitis at risk | NUMBER |
| SECONDARY | Glaucoma - Incident | 24 months | Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set. | percentage of eyes with uveitis at risk | NUMBER |
| 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. | 24 months | Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set. | percentage of eyes with uveitis at risk | NUMBER |
| SECONDARY | Intraocular Pressure - IOP-lowering Surgery | 24 months | Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set. | percentage of eyes with uveitis at risk | NUMBER |
| SECONDARY | Cataract - Incident Cataract | 24 months | Eyes with uveitis, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set. | percentage of eyes with uveitis at risk | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Flucinolone Acetonide Implant | 6.0 | Standard Error 1.4 | letters | |
| 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 | Systemic Therapy | 3.2 | Standard Error 1.4 | letters | |
| Macular Edema | Flucinolone Acetonide Implant | 22 | 95% Confidence Interval 14 to 30 | percentage of eyes with uveitis | |
| Macular Edema | Systemic Therapy | 30 | 95% Confidence Interval 21 to 40 | percentage of eyes with uveitis | |
| Uveitis Activity | Fluocinolone Acetonide Implant | 12 | 95% Confidence Interval 06 to 20 | percentage of eyes with uveitis | |
| Uveitis Activity | Systemic Therapy | 29 | 95% Confidence Interval 21 to 39 | percentage of eyes with uveitis | |
| Intraocular Pressure - Incident IOP Greater Than or Equal to 30 mm Hg | Flucinolone Acetonide Implant | 32.8 | 95% Confidence Interval 27.1 to 39.2 | percentage of eyes with uveitis at risk | |
| Intraocular Pressure - Incident IOP Greater Than or Equal to 30 mm Hg | Systemic Therapy | 6.3 | 95% Confidence Interval 3.7 to 10.3 | percentage of eyes with uveitis at risk | |
| Intraocular Pressure - Incident IOP Greater Than or Equal to 24 mm Hg | Flucinolone Acetonide Implant | 53.1 | 95% Confidence Interval 46.9 to 59.7 | percentage of eyes with uveitis at risk | |
| Intraocular Pressure - Incident IOP Greater Than or Equal to 24 mm Hg | Systemic Therapy | 18.7 | 95% Confidence Interval 14.2 to 24.5 | percentage of eyes with uveitis at risk |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Flucinolone Acetonide Intraocular Implant | 129 | |
| Overall Study | STARTED | Standard Systemic Treatment | 126 | |
| Overall Study | COMPLETED | Flucinolone Acetonide Intraocular Implant | 118 | |
| Overall Study | COMPLETED | Standard Systemic Treatment | 114 | |
| Overall Study | NOT COMPLETED | Flucinolone Acetonide Intraocular Implant | 11 | |
| Overall Study | NOT COMPLETED | Standard Systemic Treatment | 12 |
Source ClinicalTrials.gov
Adverse events166
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hyperglycemia (fasting) | Metabolism and nutrition disorders | Flucinolone Acetonide Implant | 4 | 129 | 4 |
| other | Hyperglycemia (fasting) | Metabolism and nutrition disorders | Systemic Therapy | 10 | 126 | 16 |
| other | Hyperglycemia (casual) | Metabolism and nutrition disorders | Flucinolone Acetonide Implant | 6 | 129 | 8 |
| other | Hyperglycemia (casual) | Metabolism and nutrition disorders | Systemic Therapy | 10 | 126 | 16 |
| other | Hypoglycemia | Metabolism and nutrition disorders | Flucinolone Acetonide Implant | 7 | 129 | 8 |
| other | Hypoglycemia | Metabolism and nutrition disorders | Systemic Therapy | 6 | 126 | 6 |
| other | Triglyceride (high) | Metabolism and nutrition disorders | Flucinolone Acetonide Implant | 10 | 129 | 12 |
| other | Triglyceride (high) | Metabolism and nutrition disorders | Systemic Therapy | 10 | 126 | 12 |
| other | SGOT (AST) or SGPT (ALT) | Hepatobiliary disorders | Flucinolone Acetonide Implant | 5 | 129 | 9 |
| other | SGOT (AST) or SGPT (ALT) | Hepatobiliary disorders | Systemic Therapy | 8 | 126 | 13 |
1 to 10 of 166Source ClinicalTrials.gov
See all 166 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Flucinolone Acetonide Implant | ||
| Total, all-cause mortality | Systemic Therapy | ||
| Total, other adverse events | Flucinolone Acetonide Implant | 113 | 129 |
| Total, other adverse events | Systemic Therapy | 113 | 126 |
| Total, serious adverse events | Flucinolone Acetonide Implant | 75 | 129 |
| Total, serious adverse events | Systemic Therapy | 47 | 126 |
Source ClinicalTrials.gov
Papers11
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10EY014660 | Competitive Renewal for Multicenter Uveitis Steroid Treatment (MUST) Trial | HOLBROOK, JANET T. | JOHNS HOPKINS UNIVERSITY | NATIONAL EYE INSTITUTE | 2004 to 2016 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Flucinolone Acetonide Implant vs Systemic Therapy: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00132691
GET https://conductscience.org/api/trials/v1/NCT00132691/results?page=2