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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Rahul Khurana, M.D., Northern California Retina Vitreous Associates
ClinicalTrials.gov Identifier:
NCT01870440
First received: May 24, 2013
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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
Uveitis
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 ]

Estimated Enrollment: 10
Study Start Date: May 2013
Estimated Study Completion Date: February 2015
Estimated 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01870440

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

Publications:
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: July 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northern California Retina Vitreous Associates:
Uveitis
Macular Edema

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

ClinicalTrials.gov processed this record on November 25, 2014