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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02049476
Other study ID # NA_00088146
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 2014
Est. completion date June 30, 2018

Study information

Verified date June 2019
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexamethasone pellet
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.

Locations

Country Name City State
United States The Wilmer Eye Institute, Johns Hopkins Hospital Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University Allergan

Country where clinical trial is conducted

United States, 

Outcome

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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