Clinical Trial: Multicenter Uveitis Steroid Treatment (MUST) Trial

This study is currently recruiting patients.
Verified by National Eye Institute (NEI) August 2005

Sponsored by: National Eye Institute (NEI)
Information provided by: National Eye Institute (NEI)
ClinicalTrials.gov Identifier: NCT00132691

Purpose

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.
Condition Intervention Phase
non infectious intermediate uveitis
Posterior Uveitis
Panuveitis
 Device: fluocinolone acetonide intraocular implant
 Drug: oral corticosteroid
Phase II

MedlinePlus related topics:  Eye Diseases

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further Study Details: 
Primary Outcomes: Detect differences in visual acuity
Expected Total Enrollment:  400

Study start: July 2005

The MUST trial is a randomized controlled clinical trial comparing two treatments for patients with vision-threatening non-infectious intermediate uveitis, posterior uveitis, or panuveitis: 1) local therapy with fluocinolone acetonide intraocular implant in affected eyes; versus 2) standard therapy: systemic corticosteroid therapy supplemented, when indicated, by corticosteroid-sparing potent immuno-modulator therapy. Study ophthalmologists, clinic coordinators, and patients will not be masked to treatment assignment. Masking will be applied to the determination of visual function (at the six month visit and thereafter), those outcomes based on photographic reading, blood pressure measurements, laboratory studies, and diagnosis of glaucoma by the glaucoma outcomes committee. Patients will be followed until death, participant withdrawal, or a common study closeout. Patients will be seen at baseline, one month after randomization, three months after randomization, and every three months thereafter for data collection. Both ophthalmological and medical data will be collected to evaluate the outcomes of treatment of the uveitis, complications of the uveitis, and complications from therapy itself. Selected laboratory data related to the complications from systemic corticosteroid therapy will be collected.

The planned sample size of 400 patients, 200 per treatment group, is expected to give sufficient power to detect clinically important differences in visual acuity outcomes. Patients meeting the eligibility criteria detailed above will be enrolled at approximately 22 clinical centers in the United States and randomized on a 1:1 basis to one of the two treatment groups.

Eligibility

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • age 13 years or older
  • best-corrected visual acuity of 20/200 in at least one eye with severe uveitis
  • intraocular pressure 24 mm Hg or less in all eyes with severe uveitis
  • media clarity sufficient to allow visualization and imaging of the fundus in at least one eye with severe uveitis

Exclusion Criteria:

  • inadequately controlled diabetes
  • uncontrolled glaucoma or glaucoma requiring more than one anti-glaucoma medication in one or more eyes with severe uveitis
  • advanced glaucomatous optic nerve injury
  • a history of scleritis; presence of an ocular toxoplasmosis scar
  • HIV infection or other immunodeficiency disease for which corticosteroid therapy would be contraindicated according to best medical judgment

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00132691

Natalie Kurinij      3014512020    kurinij@nei.nih.gov

Maryland
      Wilmer Eye Institute, Baltimore,  Maryland,  21205,  United States; Recruiting

Study chairs or principal investigators

Douglas Jabs,  Study Chair,  Wilmer Eye Institute   
John Kempen,  Study Chair,  Wilmer Eye Institute   

More Information

Study ID Numbers:  NEI-00; 1U10EY014660-2
Last Updated:  August 19, 2005
Record first received:  August 19, 2005
ClinicalTrials.gov Identifier:  NCT00132691
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23

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