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

This study has been completed.
Information provided by (Responsible Party):
Rahul Khurana, M.D., Northern California Retina Vitreous Associates
ClinicalTrials.gov Identifier:
First received: May 24, 2013
Last updated: March 9, 2015
Last verified: March 2015
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 Intervention Phase
Macular Edema
Drug: Ozurdex Intravitreal Injection (0.7 mg)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TAHOE: Sustained InTravitreal DexAmetHasone Implant (Ozurdex) for Uveitic Macular Edema

Resource links provided by NLM:

Further study details as provided by Northern California Retina Vitreous Associates:

Primary Outcome Measures:
  • Best Corrected Visual Acuity (using Early Treatment Diabetic Retinopathy Study Protocal) [ Time Frame: Day 90 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Central Subfoveal Retinal Thickness [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Central Subfoveal Retinal Thickness [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
  • Best Corrected Visual Acuity [ Time Frame: Day 180 ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: May 2013
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ozurdex Injection
Ozurdex Intravitreal Injection (0.7 mg)
Drug: Ozurdex Intravitreal Injection (0.7 mg)
Intravitreal Injection
Other Name: Ozurdex (0.7 mg)

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01870440

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

Responsible Party: Rahul Khurana, M.D., Principal Investigator, Northern California Retina Vitreous Associates
ClinicalTrials.gov Identifier: NCT01870440     History of Changes
Other Study ID Numbers: NCRVA-2013-Ozurdex-16.2 
Study First Received: May 24, 2013
Last Updated: March 9, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Northern California Retina Vitreous Associates:
Macular Edema

Additional relevant MeSH terms:
Macular Edema
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Signs and Symptoms
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Enzyme Inhibitors
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on May 26, 2016