The multicenter uveitis steroid treatment trial: rationale, design, and baseline characteristics.
OBJECTIVE
To describe the design and methods of the Multicenter Uveitis Steroid Treatment (MUST) trial and the baseline characteristics of enrolled patients.


METHODS
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.
Center for Preventive Ophthalmology and Biostatistics, Department of Ophthalmology, University of Pennsylvania, 3535 Market Street, Suite 700, Philadelphia, PA 19104, USA. john.kempen@uphs.upenn.edu
Kempen
John H
JH
Altaweel
Michael M
MM
Holbrook
Janet T
JT
Jabs
Douglas A
DA
Sugar
Elizabeth A
EA
D000284:Administration, Oral; D000328:Adult; D004343:Drug Implants; D005260:Female; D005446:Fluocinolone Acetonide / Q000008:administration & dosage*; D005451:Fluorescein Angiography; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012107:Research Design; D018434:Sickness Impact Profile; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014605:Uveitis / Q000188:drug therapy*; D014792:Visual Acuity / Q000502:physiology
D004343:Drug Implants; D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D005446:Fluocinolone Acetonide