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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01870440
Recruitment Status : Completed
First Posted : June 6, 2013
Last Update Posted : March 11, 2015
Information provided by (Responsible Party):
Rahul Khurana, M.D., Northern California Retina Vitreous Associates

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Macular Edema Uveitis Drug: Ozurdex Intravitreal Injection (0.7 mg) Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TAHOE: Sustained InTravitreal DexAmetHasone Implant (Ozurdex) for Uveitic Macular Edema
Study Start Date : May 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Arm Intervention/treatment
Experimental: Ozurdex Injection
Ozurdex Intravitreal Injection (0.7 mg)
Drug: Ozurdex Intravitreal Injection (0.7 mg)
Intravitreal Injection
Other Name: Ozurdex (0.7 mg)

Primary Outcome Measures :
  1. Best Corrected Visual Acuity (using Early Treatment Diabetic Retinopathy Study Protocal) [ Time Frame: Day 90 ]

Secondary Outcome Measures :
  1. Central Subfoveal Retinal Thickness [ Time Frame: Day 90 ]
  2. Central Subfoveal Retinal Thickness [ Time Frame: Day 180 ]
  3. Best Corrected Visual Acuity [ Time Frame: Day 180 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01870440

United States, California
Northern California Retina Vitreous Associates
Mountain View, California, United States, 94040
Sponsors and Collaborators
Northern California Retina Vitreous Associates

Responsible Party: Rahul Khurana, M.D., Principal Investigator, Northern California Retina Vitreous Associates Identifier: NCT01870440     History of Changes
Other Study ID Numbers: NCRVA-2013-Ozurdex-16.2
First Posted: June 6, 2013    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015

Keywords provided by Rahul Khurana, M.D., Northern California Retina Vitreous Associates:
Macular Edema

Additional relevant MeSH terms:
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Uveal Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action