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

March 9, 2015 updated by: Rahul Khurana, M.D., Northern California Retina Vitreous Associates

TAHOE: Sustained InTravitreal DexAmetHasone Implant (Ozurdex) for Uveitic Macular Edema

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Mountain View, California, United States, 94040
        • Northern California Retina Vitreous Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ozurdex Injection
Ozurdex Intravitreal Injection (0.7 mg)
Drug: Ozurdex Intravitreal Injection (0.7 mg)
Intravitreal Injection
Other Names:
  • Ozurdex (0.7 mg)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern California Retina Vitreous Associates

Collaborators

Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

May 24, 2013

First Submitted That Met QC Criteria

June 5, 2013

First Posted (Estimate)

June 6, 2013

Study Record Updates

Last Update Posted (Estimate)

March 11, 2015

Last Update Submitted That Met QC Criteria

March 9, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCRVA-2013-Ozurdex-16.2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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