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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Macular Edema, Uveitis

Intervention / Treatment
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* Drug: Ozurdex Intravitreal Injection (0.7 mg)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ozurdex Injection<br>Ozurdex Intravitreal Injection (0.7 mg) | Drug: Ozurdex Intravitreal Injection (0.7 mg)<br>* Intravitreal Injection<br>* Other names: Ozurdex (0.7 mg);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity (using Early Treatment Diabetic Retinopathy Study Protocal) |  | Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Subfoveal Retinal Thickness |  | Day 90 | 
| Central Subfoveal Retinal Thickness |  | Day 180 | 
| Best Corrected Visual Acuity |  | Day 180 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uveitis, Macular Edema