Multi-Center Uveitis Steroid Treatment (MUST) TrialSponsored by National Eye Institute (NEI) Study Summary Dr. Debra Goldstein of The University of Illinois at Chicago is conducting a study to compare the effectiveness of standardized systemic therapy vs. fluocinolone acetonide implant therapy for the treatment of severe cases of chronic, non-infectious intermediate, posterior, or panuveitis. Uveitis refers to inflammation inside the eye. This may be present as blurred vision, floaters (seeing spots), pain or redness.Uveitis can decrease your vision. The standard treatment when uveitis is severe has been oral corticosteroids or other systemic therapies. The new treatment, the fluocinolone acetonide implant, is surgically placed into the eye. The implant slowly releases anti-inflammatory medicine for about two and a half years to reduce inflammation. The FDA (Food and Drug Administration) approved the implant in April 2005. If you qualify and agree to participate , the treatment you will receive will be randomly assigned. A computer will randomly (like flipping a coin) assign you to one treatment or the other. If you are assigned to the implant treatment, you will receive implants in one or both eyes, depending on whether one or both of your eyes need such treatment. If you are assigned to standard treatment, you will receive oral therapy, which has been the standard of care for the treatment of uveitis for many years. If you participate in this study, you will receive either the implant treatment or the standard treatment for uveitis. Both of these treatments are effective in treating uveitis. There is no experimental treatment in this study, however, improvement cannot be guaranteed. You may help future patients by providing important information about the treatment of uveitis. Since chronic disease lasts for many years, information gained from this study may also influence your own future care as well. If you join this study, you will be asked to take part for up to 4 years. Patients who join the study earlier will be followed for a longer period than patients who join later. There will be 5 study visits in the first year and 4 study visits per year (for three years) after that, totaling 17 scheduled visits to complete the study. Subjects will receive $50 per study visit to cover any travel/parking expenses related to participation in this study. Participation Criteria To be considered for enrollment in this study, you must:
Principal Investigator: Debra Goldstein, MD Department: Ophthalmology
|