Study of the Effectiveness of Ozurdex for the Control of Uveitis
| Status: | Recruiting |
|---|---|
| Conditions: | Cervical Cancer, Ocular |
| Therapuetic Areas: | Oncology, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/14/2019 |
| Start Date: | January 2014 |
| End Date: | June 30, 2019 |
| Contact: | Irfan Khan, MD |
| Email: | ikhan11@jhmi.edu |
| Phone: | 4109552966 |
Study of the Effectiveness of Ozurdex in Lieu of Oral Corticosteroids for the Control of Active Intermediate and Posterior Uveitis Requiring Immunosuppressive Drug Therapy
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.
(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.
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.
(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 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 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.
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