Study of the Effectiveness of Ozurdex for the Control of Uveitis
Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Uveitis, Intermediate; Uveitis, Posterior
Intervention: Dexamethasone pellet (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Johns Hopkins University Official(s) and/or principal investigator(s): Jennifer E Thorne, MD, PhD, Principal Investigator, Affiliation: Chief, Division of Ocular Immunology, Department of Ophthalmology, Johns Hopkins School of Medicine,
Overall contact: Ahmadreza Moradi, MD, Phone: 410-502-6782, Email: amoradi1@jhmi.edu
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 Details
Official title: Study of the Effectiveness of Ozurdex in Lieu of Oral Corticosteroids for the Control of Active Intermediate and Posterior Uveitis Requiring Immunosuppressive Drug Therapy
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Control of intraocular inflammation
Secondary outcome: Control of intraocular inflammation
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 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
- 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.
Locations and Contacts
Ahmadreza Moradi, MD, Phone: 410-502-6782, Email: amoradi1@jhmi.edu
The Wilmer Eye Institute, Johns Hopkins Hospital, Baltimore, Maryland 21287, United States; Recruiting Ahmadreza Moradi, MD, Phone: 410-502-6782, Email: amoradi1@jhmi.edu Jennifer E Thorne, MD, PhD, Phone: 410-955-2966, Email: jthonre@jhmi.edu Ahmadreza Moradi, MD, Sub-Investigator Nicholas J Butler, MD, Sub-Investigator Theresa G Leung, MD, Sub-Investigator Bryn Burkholder, MD, Sub-Investigator Trucian Ostheimer, MD, Sub-Investigator Ashley Laing, MD, Sub-Investigator
Additional Information
Starting date: January 2014
Last updated: January 28, 2014
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