Study of the Effectiveness of Ozurdex for the Control of Uveitis
Condition: Uveitis, Intermediate; Uveitis, Posterior
MeSH terms: Uveitis; Uveitis, Posterior; Uveitis, Intermediate; Pars Planitis
Intervention: Dexamethasone pellet
Intervention description: Dexamethasone pellet placement occurs within 14 days of baseline examination; for patients with bilaterally active uveitis, placement of a dexamethasone pellet in the second eye should occur within 14 days of the first implantation or within 30 day of the baseline examination.
Repeated placement is permitted every 3 months based on the best clinical judgment of the doctor and the study protocol.
Intervention MeSH terms: Dexamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Uveitis, Intermediate; Uveitis, Posterior; Dexamethasone; Immunosuppressive Agents; Eye Abnormalities; Eye Diseases; Ophthalmology; Ophthalmologic Surgical Procedures; Vision Disorders; Inflammation

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.
    

Eligibility 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.