The Multicenter Uveitis Steroid Treatment Trial: Rationale, Design, and Baseline Characteristics

Accepted 13 November 2009. published online 25 January 2010.

Purpose

To describe the design and methods of the Multicenter Uveitis Steroid Treatment (MUST) trial and the baseline characteristics of enrolled patients.

Design

Baseline data from a 1:1 randomized, parallel treatment design clinical trial at 23 clinical centers comparing systemic corticosteroid therapy (and immunosuppression when indicated) with fluocinolone acetonide implant placement.

Methods

Eligible patients had active or recently active noninfectious intermediate uveitis, posterior uveitis, or panuveitis. The study design had 90% power (2-sided type I error rate, 0.05) to detect a 7.5-letter (1.5-line) difference between groups in the mean visual acuity change between baseline and 2 years. Secondary outcomes include ocular and systemic complications of therapy and quality of life. Baseline characteristics include demographic and clinical characteristics, quality of life, and reading center gradings of lens and fundus photographs, optical coherence tomography images, and fluorescein angiograms.

Results

Over 3 years, 255 patients were enrolled (481 eyes with uveitis). At baseline, 50% of eyes with uveitis had best-corrected visual acuity worse than 20/40 (16% worse than 20/200). Lens opacities (39% of gradeable phakic eyes), macular edema (36%), and epiretinal membrane (48%) were common. Mean health utility was 74.1.

Conclusions

The MUST trial will compare fluocinolone acetonide implant versus systemic therapy for management of intermediate uveitis, posterior uveitis, and panuveitis. Patients with intermediate uveitis, posterior uveitis, or panuveitis enrolled in the trial had a high burden of reduced visual acuity, cataract, macular edema, and epiretinal membrane; overall quality of life was lower than expected based on visual acuity.

a Ocular Inflammation Service, Department of Ophthalmology/Scheie Eye Institute, University of Pennsylvania, Philadelphia, Pennsylvania

b Center for Preventive Ophthalmology and Biostatistics, Department of Ophthalmology/Scheie Eye Institute, University of Pennsylvania, Philadelphia, Pennsylvania

c Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania

d Fundus Photograph Reading Center, Department of Ophthalmology, University of Wisconsin, Madison, Wisconsin

e Center for Clinical Trials, The Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland

f Department of Epidemiology, The Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland

g Department of Biostatistics, The Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland

h Departments of Ophthalmology and Medicine, The Mount Sinai School of Medicine, New York, New York

Inquiries to John H. Kempen, Center for Preventive Ophthalmology and Biostatistics, Department of Ophthalmology, University of Pennsylvania, 3535 Market Street, Suite 700, Philadelphia, PA 19104; e-mail: john.kempen@uphs.upenn.edu

Douglas A. Jabs, MUST Chairman's Office, Department of Ophthalmology, Mount Sinai School of Medicine, One Gustave L. Levy Place, Box 1183, New York, NY 10029-6574; e-mail: douglas.jabs@mssm.edu

Supplemental Material available at AJO.com.

⁎ Writing Committee: John H. Kempen, Michael M. Altaweel, Janet T. Holbrook, Douglas A. Jabs, and Elizabeth A. Sugar.

PII: S0002-9394(09)00882-4

doi:10.1016/j.ajo.2009.11.019

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