Uveitis, Posterior Clinical Trial
Official title:
Proof of Concept Study of the Effectiveness of Ozurdex in Lieu of Oral Corticosteroids for the Control of Active Intermediate and Posterior Uveitis Requiring Immunosuppressive Drug Therapy
Verified date | June 2019 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 30, 2018 |
Est. primary completion date | June 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | The Wilmer Eye Institute, Johns Hopkins Hospital | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Allergan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Mean Intraocular Pressure (IOP) | Mean IOP (mmHg) was calculated at each visit | Baseline, 1 month, 3 months, 6 months, and 12 months visit | |
Other | Number of Eyes With a Need for Cataract Surgery | Number of eyes that had progression of cataract defined as any interval increase in nuclear, cortical or posterior sub capsular cataract from a previous visit that resulted in cataract surgery. | Baseline, 1 month, 3 months, 6 months, and 12 months visit | |
Primary | Number of Participants With Absence of Intraocular Inflammation at 6 Months | Absence of intraocular inflammation (e.g. less than trace anterior chamber (AC) cells; no vitreous haze; inactive chorioretinal lesions) is used to assess control of intraocular inflammation following treatment. | at 6-month visit | |
Secondary | Number of Participants With Absence of Intraocular Inflammation at 12 Months | Absence of intraocular inflammation (e.g. less than trace anterior chamber (AC) cells; no vitreous haze; inactive chorioretinal lesions) is used to assess control of intraocular inflammation following treatment. | 12-month clinical visit |
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