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

Overview

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 Title of Study: “TAHOE: Sustained InTravitreal DexAmetHasone Implant (Ozurdex) for Uveitic Macular Edema”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2015

Detailed 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.

Interventions

  • Drug: Ozurdex Intravitreal Injection (0.7 mg)
    • Intravitreal Injection

Arms, Groups and Cohorts

  • Experimental: Ozurdex Injection
    • Ozurdex Intravitreal Injection (0.7 mg)

Clinical Trial Outcome Measures

Primary Measures

  • Best Corrected Visual Acuity (using Early Treatment Diabetic Retinopathy Study Protocal)
    • Time Frame: Day 90

Secondary Measures

  • Central Subfoveal Retinal Thickness
    • Time Frame: Day 90
  • Central Subfoveal Retinal Thickness
    • Time Frame: Day 180
  • Best Corrected Visual Acuity
    • Time Frame: Day 180

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Northern California Retina Vitreous Associates
  • Collaborator
    • Allergan
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rahul Khurana, M.D., Principal Investigator – Northern California Retina Vitreous Associates

References

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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