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Multicenter Uveitis Steroid Treatment (MUST) Trial

NCT00132691 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2016-11-25

Study results available
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Summary

The purpose of this study is to compare the effectiveness of standardized systemic therapy versus fluocinolone acetonide implant therapy for the treatment of severe cases of non-infectious intermediate uveitis, posterior uveitis, or panuveitis.

Conditions

  • Uveitis

Interventions

DRUG

fluocinolone acetonide intraocular implant

RETISERT™ (fluocinolone acetonide intravitreal implant) 0.59 mg is a sterile implant designed to release fluocinolone acetonide locally to the posterior segment of the eye at a nominal initial rate of 0.6 μg/day, decreasing over the first month to a steady state between 0.3-0.4 μg/day over approximately 30 months.

DRUG

oral corticosteroid with immunosuppressive agents as needed

Prednisone

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • JHSPH Center for Clinical Trials

    lead OTHER

Principal Investigators

  • Douglas Jabs, MD, MBA · Icahn School of Medicine at Mount Sinai

  • John Kempen, MD, PhD · Scheie Eye Center, University of Pennsylvania

  • Janet T Holbrook, PhD, MPH · Director of Coordinating Cener, Johns Hopkins Bloomberg School of Public Health

  • Michael Altaweel, MD · Director of Fundus Photography Reading Center, University of Wisconsin at Madison

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States
  • Australia
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00132691 on ClinicalTrials.gov