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OpenTrials
Completed

NCT Number: NCT01870440

TAHOE: 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ozurdex Intravitreal Injection (0.7 mg)

Drug

Intravitreal Injection

Other names: Ozurdex (0.7 mg)

Primary outcomes

  1. Best Corrected Visual Acuity (using Early Treatment Diabetic Retinopathy Study Protocal)

    Time frame: Day 90

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Northern California Retina Vitreous Associates

Other

Collaborators

  • Allergan

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 6, 2013
Registry last updated
Mar 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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