Uveitis is a major cause of visual loss and blindness in the United States. The Multicenter Uveitis Steroid Treatment (MUST) Trial will be a multicenter, randomized controlled clinical trial to compare the fluocinolone acetonide implant to """"""""standard therapy"""""""" for the treatment of patients with severe, vision threatening intermediate, posterior, or panuveitis. Patients with active uveitis will be randomized to treatment with either the fluocinolone acetonide implant or """"""""standard therapy"""""""" consisting of oral corticosteroids. Supplementary immunosuppressive drugs will be used according to standardized guidelines. The design outcome will be loss of visual acuity;other outcomes include ability to control the uveitis, resolution of macular edema (a major cause of visual loss in these patients), and ocular and systemic morbidity from both the disease and the treatments. Additional benefits include prospective epidemiologic data on the long-term outcomes of uveitis, its complications, treatments and their complications. We propose to establish a Reading Center for the MUST Trial at the University of Wisconsin - Madison (UW RC). Stereoscopic color fundus photographs and fluorescein angiograms and ocular coherence tomograms (OCT scans), will be evaluated for presence and severity of macular edema (degree of retinal thickening macular center, and areas of thickening, cystoid change, and fluorescein leakage). Photographs and angiograms will also be assessed for vascular nonperfusion, hemorrhage, retinal detachment, epiretinal membrane, glaucomatous disc changes, and nuclear and posterior subcapsular cataract. The UW RC will be responsible for proposing and implementing imaging and grading protocols, monitoring and controlling the quality of imaging and grading, maintaining appropriate organization and procedures to handle study images and grading data, and summarizing grading data into analysis variables. In collaboration with the Study Chairman's Office, the Coordinating Center, and other investigators, the UW RC will participate in the design, conduct, analysis and reporting of the MUST Trial.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
3U10EY014656-05S1
Application #
7809032
Study Section
Special Emphasis Panel (ZEY1-VSN (09))
Program Officer
Kurinij, Natalie
Project Start
2004-07-15
Project End
2012-04-30
Budget Start
2008-05-01
Budget End
2012-04-30
Support Year
5
Fiscal Year
2009
Total Cost
$484,596
Indirect Cost
Name
University of Wisconsin Madison
Department
Ophthalmology
Type
Schools of Medicine
DUNS #
161202122
City
Madison
State
WI
Country
United States
Zip Code
53715
Sugar, Elizabeth A; Venugopal, Vidya; Thorne, Jennifer E et al. (2017) Longitudinal Vision-Related Quality of Life for Patients with Noninfectious Uveitis Treated with Fluocinolone Acetonide Implant or Systemic Corticosteroid Therapy. Ophthalmology 124:1662-1669
Writing Committee for the Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study Research Group; Kempen, John H; Altaweel, Michael M et al. (2017) Association Between Long-Lasting Intravitreous Fluocinolone Acetonide Implant vs Systemic Anti-inflammatory Therapy and Visual Acuity at 7 Years Among Patients With Intermediate, Posterior, or Panuveitis. JAMA 317:1993-2005
Sen, H Nida; Abreu, Francis M; Louis, Thomas A et al. (2016) Cataract Surgery Outcomes in Uveitis: The Multicenter Uveitis Steroid Treatment Trial. Ophthalmology 123:183-90
Holbrook, Janet T; Sugar, Elizabeth A; Burke, Alyce E et al. (2016) Dissociations of the Fluocinolone Acetonide Implant: The Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study. Am J Ophthalmol 164:29-36
Altaweel, Michael M; Gangaputra, Sapna S; Thorne, Jennifer E et al. (2016) Morphological assessment of the retina in uveitis. J Ophthalmic Inflamm Infect 6:33
Yu, Tsung; Holbrook, Janet T; Thorne, Jennifer E et al. (2016) Using a patient-centered approach to benefit-harm assessment in treatment decision-making: a case study in uveitis. Pharmacoepidemiol Drug Saf 25:363-71
Kempen, John H; Van Natta, Mark L; Altaweel, Michael M et al. (2015) Factors Predicting Visual Acuity Outcome in Intermediate, Posterior, and Panuveitis: The Multicenter Uveitis Steroid Treatment (MUST) Trial. Am J Ophthalmol 160:1133-1141.e9
Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group; Kempen, John H; Altaweel, Michael M et al. (2015) Benefits of Systemic Anti-inflammatory Therapy versus Fluocinolone Acetonide Intraocular Implant for Intermediate Uveitis, Posterior Uveitis, and Panuveitis: Fifty-four-Month Results of the Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Ophthalmology 122:1967-75
Multicenter Uveitis Steroid Treatment (MUST) Trial Follow-up Study Research Group (2015) Quality of Life and Risks Associated with Systemic Anti-inflammatory Therapy versus Fluocinolone Acetonide Intraocular Implant for Intermediate Uveitis, Posterior Uveitis, or Panuveitis: Fifty-four-Month Results of the Multicenter Uveitis Steroid Treatmen Ophthalmology 122:1976-86
Yu, Tsung; Holbrook, Janet T; Thorne, Jennifer E et al. (2015) Outcome Preferences in Patients With Noninfectious Uveitis: Results of a Best-Worst Scaling Study. Invest Ophthalmol Vis Sci 56:6864-72

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