Study of the Effectiveness of Ozurdex for the Control of Uveitis

• Status: Completed
• Trial end date: 2018-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Allergan
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Immunosuppressive Agents

Criteria

Inclusion Criteria:

• Active sight-threatening intermediate or posterior uveitis for which immunosuppressive drug therapy is planned and the physician is considering treatment with high-dose corticosteroid to control the uveitis whilst immunosuppressive drugs are being instituted or adjusted. Note: it is acceptable for the patient to already be on an immunosuppressive drug as long as high dose corticosteroids are indicated.

• Patients must be age 18 years or older (the dexamethasone pellet is not FDA-approved for pediatric use) and sign an informed consent.

• The ocular media must be clear enough to obtain optical coherence photography (OCT) and fundus photographs.

• No elective intraocular surgery should be planned for the first 3 months after enrollment.

Exclusion Criteria:

• Infectious uveitis

• History of scleritis

• Active or suspected viral infection of the cornea or conjunctiva

• History of mycobacterial or fungal disease

• HIV positivity

• Age <18 years old

• Allergy to dexamethasone

• Uncontrolled intraocular pressure (IOP)

• Advanced glaucoma

• Aphakia with rupture of the posterior lens capsule

• Anterior chamber IntraOcualr Lens (ACIOL) with rupture of the posterior lens capsule

• Media opacity that would preclude evaluation of the posterior pole via fundus photography or OCT assessment

• Planned elective ocular surgery within 3 months of enrollment

• Any systemic disease requiring systemic corticosteroids.