Recruitment

Recruitment Status
Completed

Inclusion Criterias

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

Exclusion Criterias

Infectious uveitis
Allergy to dexamethasone
Uncontrolled intraocular pressure (IOP)
...
Infectious uveitis
Allergy to dexamethasone
Uncontrolled intraocular pressure (IOP)
HIV positivity
Media opacity that would preclude evaluation of the posterior pole via fundus photography or OCT assessment
Active or suspected viral infection of the cornea or conjunctiva
Aphakia with rupture of the posterior lens capsule
History of scleritis
Anterior chamber IntraOcualr Lens (ACIOL) with rupture of the posterior lens capsule
Any systemic disease requiring systemic corticosteroids.
History of mycobacterial or fungal disease
Age <18 years old
Advanced glaucoma
Planned elective ocular surgery within 3 months of enrollment

Summary

Conditions
  • Uveitis, Intermediate
  • Uveitis, Posterior
Type
Interventional
Phase
Phase 4
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 t...

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.

Inclusion Criterias

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

Exclusion Criterias

Infectious uveitis
Allergy to dexamethasone
Uncontrolled intraocular pressure (IOP)
...
Infectious uveitis
Allergy to dexamethasone
Uncontrolled intraocular pressure (IOP)
HIV positivity
Media opacity that would preclude evaluation of the posterior pole via fundus photography or OCT assessment
Active or suspected viral infection of the cornea or conjunctiva
Aphakia with rupture of the posterior lens capsule
History of scleritis
Anterior chamber IntraOcualr Lens (ACIOL) with rupture of the posterior lens capsule
Any systemic disease requiring systemic corticosteroids.
History of mycobacterial or fungal disease
Age <18 years old
Advanced glaucoma
Planned elective ocular surgery within 3 months of enrollment

Locations

Baltimore, Maryland, 21287
Baltimore, Maryland, 21287

Tracking Information

NCT #
NCT02049476
Collaborators
Allergan
Investigators
  • Principal Investigator: Jennifer E Thorne, MD, PhD Department of Ophthalmology, Johns Hopkins School of Medicine,
  • Jennifer E Thorne, MD, PhD Department of Ophthalmology, Johns Hopkins School of Medicine,