New York, NY – A team of researchers comparing the two leading treatment approaches for the eye condition uveitis, which is the fifth leading cause of blindness in the US, have found that a time-release corticosteroid implant placed surgically in the eye is similarly effective in treating the disease as anti-inflammatory corticosteroids and immunosuppressive drugs taken orally. The report was published online today in the journal Ophthalmology.
Uveitis is a collection of diseases characterized by inflammation inside the eye that damage the eye tissues, and without aggressive treatment will often lead to blindness at a relatively early age. Conventional treatment generally has called for patients to take corticosteroid and immunosuppressive drug pills long-term, as the disease often recurs when treatment is stopped.
In 2005, the Food and Drug Administration (FDA) approved for treatment of severe uveitis an intraocular implant that is surgically inserted into the eye and slowly releases corticosteroid medication over a period of up to three years. This new study, the Multicenter Uveitis Steroid Treatment (MUST) Trial, is the first to establish that local treatment with the intraocular implant is as effective as the standard systemic treatment in managing the condition.
“These results, showing similar effectiveness of the two treatment approaches really gives doctors and patients more options for choosing a treatment based upon their individual circumstances,” said Douglas A. Jabs, MD, MBA, Chair of the Department of Ophthalmology at Mount Sinai School of Medicine, who led the study. “With both approaches being shown to be similarly effective in preserving vision, patients, in consultation with their physicians, can select the treatment option that is right for them.”
“Additionally, the finding that long-term systemic treatment with oral corticosteroids and immunosuppressive drugs had no more systemic side effects than local therapy with the implant suggests that this approach is safe for patients with uveitis and even for those with other inflammatory diseases,” added Dr. Jabs.
The MUST Trial randomly assigned 255 patients to one of the two treatment options and monitored their vision and health for two years. Patients came from 21 healthcare facilities in the United States, as well as from two international sites in the United Kingdom and Australia.
In addition to studying the effects on vision, the study evaluated side effects of therapy and effectiveness in controlling uveitis itself. Although both treatments were effective overall at preserving vision, conventional systemic therapy with pills showed few systemic adverse effects, suggesting that systemic treatment may be safer than previously believed. Patients that received implants had more ocular adverse effects, including high eye pressure and cataracts, but implants were also found to be somewhat more effective at suppressing inflammation, the net effect of which was a similar improvement in vision to systemic therapy. Both treatment approaches were successful in controlling the inflammation in the majority of patients, but the implant worked slightly faster and in a higher percent of patients.
“The better control of the inflammation with the implant suggests that it may have a possible role for patients whose uveitis cannot be controlled with systemic therapy,” said Dr. Jabs.
The MUST Trial was supported by The National Eye Institute (NEI), which is part of The National Institutes of Health (NIH).
About The Mount Sinai Medical Center
The Mount Sinai Medical Center encompasses both The Mount Sinai Hospital and Mount Sinai School of Medicine. Established in 1968, Mount Sinai School of Medicine has more than 3,400 faculty in 32 departments and 16 institutes. It consistently ranks among the top 20 medical schools both in National Institutes of Health (NIH) funding and by U.S. News & World Report. The medical school also ranks third in NIH funding per faculty member. The school received the 2009 Spencer Foreman Award for Outstanding Community Service from the Association of American Medical Colleges.
The Mount Sinai Hospital, founded in 1852, is a 1,171-bed tertiary- and quaternary-care teaching facility and one of the nation’s oldest, largest and most-respected voluntary hospitals. In 2011, U.S. News & World Report ranked The Mount Sinai Hospital 16th on its elite honor roll of the nation’s top hospitals based on reputation, patient safety, and other patient-care factors. Of the top 20 hospitals in the United States, Mount Sinai is one of only 12 who employs a best-in-class integrated business model that seamlessly combines its management, governance and information technology with a medical school. Nearly 60,000 people were treated at Mount Sinai as inpatients last year, and approximately 560,000 outpatient visits took place.