Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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 until the disease reactivates before instituting such therapy and therefore a chronic suppressive dose is not obtained. The fluocinolone acetonide implant (Retisert®, Bausch and Lomb, Tampa, FL) is FDA-approved for the treatment of intermediate and posterior uveitis and it is equally effective in controlling uveitis as high-dose oral corticosteroids but avoids the systemic side effects associated with the use of high doses of oral corticosteroids. However, this form of local therapy has high rates of ocular side effects, including ocular hypertension causing glaucoma and/or requiring glaucoma surgery and cataracts. Furthermore, every two and half to three years the implant is exhausted of corticosteroid and therefore repeat surgical insertion of another implant may be required. A useful potential therapy for the treatment of these patients would be a shorter-acting local corticosteroid that could be delivered in conjunction with systemic immunosuppressive drug therapy that would have a lower ocular side effect profile but still would be effective enough to replace the use of high-dose systemic corticosteroids in the treatment of active intermediate or posterior uveitis. It is possible that the dexamethasone pellet could fill this unique role in the treatment of uveitis. Investigators propose this study to evaluate dexamethasone pellet for this specific use among patients with active intermediate and posterior uveitis. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02049476
Study type Interventional
Source Johns Hopkins University
Contact
Status Completed
Phase Phase 4
Start date January 2014
Completion date June 30, 2018

See also
  Status Clinical Trial Phase
Completed NCT00570479 - Prophylactic Anecortave Acetate in Patients With a Retisert Implant Phase 1
Recruiting NCT05486468 - The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment Phase 3
Terminated NCT03656692 - Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer) Phase 4
Completed NCT02255032 - Suprachoroidal Injection of Triamcinolone Acetonide in Subjects With Macular Edema Following Non-Infectious Uveitis Phase 2
Completed NCT00035906 - Research Study in Patients With Persistent Macular Edema Phase 2
Recruiting NCT05101928 - Ozurdex Monotherapy Trial Phase 4
Terminated NCT05070728 - Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert (FAI) Phase 3
Completed NCT02595398 - Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis Phase 3
Recruiting NCT03066869 - Efficacy and Safety of H.P. ACTHAR GEL in Adults With Retinal Vasculitis Phase 4
Completed NCT01539577 - A Long-Term Safety Study of OZURDEX® in Clinical Practice N/A
Recruiting NCT05322070 - Fluocinolone Acetonide Intravitreal Implant 0.18 mg in the Treatment of Chronic Non-Infectious Posterior Segment Uveitis Phase 4
Recruiting NCT06085079 - Ixekizumab for the Management of Refractory Non-Infectious Uveitis: A Proof-of-Concept Study Phase 4
Completed NCT03145025 - Corneal Endothelial Cell Density in Eyes Treated With a Fluocinolone Acetonide Intravitreal Implant
Withdrawn NCT01905124 - Safety &Efficacy of CF101 to Subjects With Uveitis Phase 2
Completed NCT03598452 - High-dose Intravitreal Injection of Ganciclovir for the Treatment of CMVR in HIV-negative Patients N/A
Completed NCT00404612 - A Study of LX211 in Active Sight Threatening, Non-infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis Phase 3
Completed NCT00404742 - A Study of LX211 in Clinically Quiescent Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis Phase 3
Completed NCT02952001 - MAGNOLIA: Extension Study of Patients With Non-infectious Uveitis Who Participated in CLS1001-301
Not yet recruiting NCT06431373 - A Study of Brepocitinib in Adults With Active, Non-Infectious, Non-Anterior Uveitis Phase 3
Completed NCT03097315 - Suprachoroidal Injection of CLS-TA in Patients With Non-infectious Uveitis Phase 3