MUST Trial

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 immunomodulator therapy.

The initial portion of the study has concluded; all patients nationwide are now enrolled in the “Follow-Up” portion. As part of the clinical trial, patients had an unprecedented amount of clinical information collected longitudinally, which provides a starting point to evaluate the long-term outcomes of patients with these severe forms of uveitis. The objectives of the MUST Trial Follow-up Study are to evaluate long term consequences of the alternative treatment regimens and to conduct broad outcomes research in this well-documented cohort.

The MUST trial, or Multicenter Uveitis Steroid Treatment (MUST) Trial, originally intended to compare the efficacy of standardized systemic therapy versus fluocinolone acetonide implant therapy for the treatment of severe cases of non-infectious intermediate uveitis, posterior uveitis or panuveitis. With the extensive clinical parameters collected on each patient, it was deemed fortuitous to continue data collection, to provide a robust data set for thorough evaluation. Approximately 250 patients were enrolled internationally in the first consortium, and are in the process of continuous follow-up. The objectives of the MUST Trial Follow-up Study are to evaluate long term consequences of the alternative treatment regimens and to conduct broad outcomes research in this well-documented cohort, specifically for approximately 8 years. Complications include cataracts, elevated IOP and glaucoma, macular edema, and epiretinal membrane problems.

Participants in this study will be followed until death, participant withdrawal, or a common study closeout. Study visits occur approximately every 6 months, coinciding with a typical routine ophthalmology visit. Ophthalmological and medical data are collected to evaluate the outcomes of treatment of the uveitis, the complications of the uveitis, and complications of therapy. Selected laboratory testing, related to the complications of systemic corticosteroid therapy, is also performed.

Patients who enrolled in the MUST Trial are eligible for the MUST Trial Follow-up Study.

More Information about the Sponsor: National Eye Institute, http://musttrial.org/.

Principal Investigator: C. Stephen Foster, M.D., F.A.C.S., F.A.C.R.

Research Coordinator: If you have any questions about the study, contact Halea Meese (hmeese@mersi.com), 781-647-1431 x 402).

If you are a study patient currently enrolled in this study, contact the Institutional Review Board, Western IRB, at 1-800-562-4789. They are able to provide information on patient’s rights.

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