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| Sponsored by: |
National Eye Institute (NEI) |
| Information provided by: | National Eye Institute (NEI) |
| ClinicalTrials.gov Identifier: | NCT00132691 |
Purpose
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.
| Condition | Intervention | Phase |
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Uveitis |
Drug: fluocinolone acetonide intraocular implant Drug: oral corticosteroid with immunosuppressive agents as needed |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Multicenter Uveitis Steroid Treatment (MUST) Trial |
| Estimated Enrollment: | 250 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1: Active Comparator
Immunosupressant medication implant
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Drug: fluocinolone acetonide intraocular implant
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.
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2: Active Comparator
Systemic immunosuppressant
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Drug: oral corticosteroid with immunosuppressive agents as needed
Prednisone
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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.
Eligibility
| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Natalie Kurinij, PhD | 3014512020 | kurinij@nei.nih.gov |
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Show 23 Study Locations |
| Study Chair: | Douglas Jabs, MD, MBA | Mount Sinai School of Medicine |
| Study Chair: | John Kempen, MD, PhD | Scheie Eye Center, University of Pennsylvania |
More Information
NEI Clinical Studies Database
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MUST, JHU, Center for Clinical Trials
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ISRCTN15396562
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| Responsible Party: | Mount Sinai School of Medicine ( Douglas A. Jabs, MD, MBA ) |
| Study ID Numbers: | NEI-106, 1U10EY014660-2, ISRCTN15396562 |
| First Received: | August 19, 2005 |
| Last Updated: | May 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00132691 |
| Health Authority: | United States: Federal Government |
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