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

• Published in: American journal of ophthalmology 2010-04, Vol.149 (4), p.550-561.e10
• Main Authors: Kempen, John H, Altaweel, Michael M, Holbrook, Janet T, Jabs, Douglas A, Sugar, Elizabeth A
• Format: Article
• Language: English
• Subjects: Administration, Oral; Adult; Awards & honors; Cataracts; Clinical trials; Drug Implants; Female; Fluocinolone Acetonide - administration & dosage; Fluorescein Angiography; Glucocorticoids - administration & dosage; Humans; Immunosuppressive Agents - administration & dosage; Macular degeneration; Male; Middle Aged; Ophthalmology; Quality of Life; Research Design; Sickness Impact Profile; Standard deviation; Studies; Tomography, Optical Coherence; Transplants & implants; Treatment Outcome; Uveitis - drug therapy; Visual Acuity - physiology
• ISSN: 0002-9394; 1879-1891
• DOI: 10.1016/j.ajo.2009.11.019

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.