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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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The purpose of this study is to determine whether an intravitreal dexamethasone implant (Ozurdex, Allergan) is effective to manage macular edema secondary to non-infectious uveitis.
Uveitis accounts for more than 10% of all cases of severe vision loss in developed countries, which makes it possibly the fourth leading cause of blindness in the United States. Cystoid macular edema (CME) is the most structural complication of uveitis, resulting in visual impairment and blindness. If left untreated or undertreated over a period of years, CME may result in permanent photoreceptor damage of the macula and loss of central vision. Further, CME may persist despite adequate control of the uveitis, and therefore, adjuvant therapy to specifically treat the CME may be required.
We propose to study whether a sustained steroid delivery system (Ozurdex, Allergan) can treat uveitic macular edema. Ozurdex has been proven to be effective for non-infectious posterior uveitis; and FDA approved for posterior uveitis. The sustained delivery of the steroid and local delivery modality makes it an ideal candidate to manage macular edema in uveitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ozurdex Injection | Experimental | Ozurdex Intravitreal Injection (0.7 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozurdex Intravitreal Injection (0.7 mg) | Drug | Intravitreal Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity (using Early Treatment Diabetic Retinopathy Study Protocal) | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Central Subfoveal Retinal Thickness | Day 90 | |
| Central Subfoveal Retinal Thickness | Day 180 | |
| Best Corrected Visual Acuity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern California Retina Vitreous Associates | Mountain View | California | 94040 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21220619 | Background | Lowder C, Belfort R Jr, Lightman S, Foster CS, Robinson MR, Schiffman RM, Li XY, Cui H, Whitcup SM; Ozurdex HURON Study Group. Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis. Arch Ophthalmol. 2011 May;129(5):545-53. doi: 10.1001/archophthalmol.2010.339. Epub 2011 Jan 10. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 1, 2019 | |
| Reset | Feb 25, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 1, 2019 | Feb 25, 2019 |
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D014605 | Uveitis |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Day 180 |
| D014603 |
| Uveal Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |