CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 255 enrolled
Drug / intervention
fluocinolone acetonide intraocular implant +1 moredrug
Likely dose
Fluocinolone acetonide intraocular implant 0.59 mg releasing 0.6 μg/day initially, decreasing to 0.3-0.4 μg/day at steady state; or oral prednisone with immunosuppressive agents as neededAI-extracted
Key inclusion· 3
  • Age 13 years or older
  • Best-corrected visual acuity of hand motions or better in at least one eye with uveitis
  • Intraocular pressure 24 mm Hg or less in all eyes with uveitis
Key exclusion· 5
  • Inadequately controlled diabetes
  • Uncontrolled glaucoma
  • Advanced glaucomatous optic nerve injury
  • History of scleritis or presence of ocular toxoplasmosis scar

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00132691
NCT00132691Phase 4Completed

Multicenter Uveitis Steroid Treatment (MUST) Trial

JHSPH Center for Clinical Trials·interventional·Posted Aug 22, 2005·Updated Nov 25, 2016

In Brief

A Phase 4 clinical trial evaluating fluocinolone acetonide intraocular implant and oral corticosteroid with immunosuppressive agents as needed for Uveitis. Completed, enrolled 255 participants across 23 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUveitis
CountriesAustralia, United Kingdom, United States

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 22, 2005
Enrollment StartSep 1, 2005
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 20.9 years ago

Interventions

fluocinolone acetonide intraocular implantdrug

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.

oral corticosteroid with immunosuppressive agents as neededdrug

Prednisone