TAHOE: Intravitreal Dexamethasone Implant (Ozurdex) for Uveitic Macular Edema



Status:Completed
Conditions:Cervical Cancer, Cardiology, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Oncology, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:May 2013
End Date:December 2014

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TAHOE: Sustained InTravitreal DexAmetHasone Implant (Ozurdex) for Uveitic Macular Edema

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.

Inclusion Criteria:

- Uveitis CME with central subfoveal thickness > 350 microns

- non-infectious uveitis

- Visual Acuity > 20/32

Exclusion Criteria:

- Visual Acuity worse than 20/200

- Moderate or severe glaucoma (as defined as >2 topical ocular medications)

- Infectious uveitis

- Patients with active or suspected ocular or periocular infections including most
viral diseases of the cornea and conjunctiva, including active epithelial herpes
simplex keratitis, vaccinia, varicella, mycobacterial infections, and fungal
diseases.

- Aphakic eyes with rupture of the posterior lens capsule

- Anterior Chamber intraocular Lens and rupture of the posterior lens capsule

- Hypersensitivity to any components of the Ozurdex
We found this trial at
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Mountain View, California 94040
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Mountain View, CA
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