Clinical Trial: Study of the Effectiveness of Ozurdex for the Control of Uveitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Study of the Effectiveness of Ozurdex in Lieu of Oral Corticosteroids for the Control of Active Intermediate and Posterior Uveitis Requiring Immunosuppressive Drug Therapy

Brief Summary:

The main purpose of this study is to evaluate whether or not the dexamethasone pellet (Ozurdex®, Allergan, Irvine, CA) can replace oral corticosteroid (e.g. prednisone) in the treatment of active sight-threatening, noninfectious intermediate and/or posterior uveitis in which immunosuppressive drug therapy is indicated.

Uveitis is an inflammation inside the eye. Uveitis can decrease patients' vision if it is not treated.

The dexamethasone pellet is an implant filled with a corticosteroid medicine. This therapy is approved by the Food and Drug Administration (FDA) for the treatment of intermediate and/or posterior uveitis.

In this study investigators want to see if using the implant together with systemic immunosuppressive drug therapy can result in lower ocular side effect profile but is effective enough to replace the use of high-dose systemic corticosteroids in the treatment of active intermediate and/or posterior uveitis. Knowing the effectiveness and safety of these treatments is important because the kinds of uveitis being studied usually need to be treated for many years. This information may help researchers understand uveitis better and may suggest ways of improving treatment.

Adult patients with intermediate and/or posterior uveitis for which immunosuppressive drug therapy with high-dose corticosteroid is planned may join.

Detailed Summary:

Objectives: This is a single arm study evaluating whether or not the dexamethasone pellet (Ozurdex®, Allergan, Irvine, CA) can replace oral corticosteroid (e.g. prednisone) in the treatment of active sight-threatening, noninfectious intermediate or posterior uveitis in which immunosuppressive drug therapy is indicated.

Background: Intermediate and posterior uveitis are thought to be severe intraocular inflammation that may lead to permanent visual loss. It is estimated that these forms of uveitis comprise the fifth or sixth leading cause of blindness and tend to affect working class age patients, thus causing loss of work hours and diminished productivity and quality of life. Because the posterior segment of the eye is not adequately treated by corticosteroid drops often systemic drug therapy is used including oral corticosteroids or prednisone. Prednisone can have a myriad of side effects in approximately one-quarter to one-third of cases treated in tertiary care centers such as ours, additional medications such as immunosuppressive drugs are required to control the disease and/or to allow for appropriate tapering of oral prednisone to subsequent levels that have a low side effect profile when delivered over a long period of time. Typically, chronic prednisone therapy in doses of 7.5 mg daily or less are thought to have a low enough side effect profile to be amenable to long-term therapy. However frequently immunosuppressive drugs are required to get the dosing to this level. There are occasions when patients are intolerant of any dose of oral corticosteroids or are intolerant of the higher doses of oral corticosteroids (30 - 60 mg daily) and therefore this treatment modality is avoided due to prednisone's attendant side effects. Although periocular and intravitreal corticosteroids injections may be performed, with these modalities the standard of care is to wait un
Sponsor: Johns Hopkins University

Current Primary Outcome: Control of intraocular inflammation [ Time Frame: at 6-month visit ]

Original Primary Outcome: Control of intraocular inflammation [ Time Frame: at 6-month visit ]

Current Secondary Outcome: Control of intraocular inflammation [ Time Frame: 12-month clinical visit ]

Original Secondary Outcome: Same as current

Information By: Johns Hopkins University

Dates:
Date Received: January 27, 2014
Date Started: January 2014
Date Completion: December 2018
Last Updated: February 25, 2016
Last Verified: February 2016