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

Northern California Retina Vitreous Associates

Status and phase: Completed; Phase 4

Conditions: Uveitis; Macular Edema

Treatments: Drug: Ozurdex Intravitreal Injection (0.7 mg)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01870440

NCRVA-2013-Ozurdex-16.2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Ozurdex Injection

Experimental group

Description:

Ozurdex Intravitreal Injection (0.7 mg)

Treatment:

Drug: Ozurdex Intravitreal Injection (0.7 mg)