Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132691
Status:
COMPLETED
Last Update Posted:
2016-11-25
First Post:
2005-08-19
Brief Title:
Multicenter Uveitis Steroid Treatment MUST Trial
Sponsor:
JHSPH Center for Clinical Trials
Organization:
JHSPH Center for Clinical Trials
Study Overview
Official Title:
Multicenter Uveitis Steroid Treatment MUST Trial
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MUST
Brief 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
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 11 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 ie 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 45 years and one after 7 years of follow-up The Data Safety Monitoring Board reviewed and approved the analysis plan
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 11 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 ie 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 45 years and one after 7 years of follow-up The Data Safety Monitoring Board reviewed and approved the analysis plan
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10EY014660 | NIH | None | None |
| 1U10EY014660-2 | None | None | None |
| ISRCTN15396562 | US NIH GrantContract | None | httpsreporternihgovquickSearchU10EY014660 |