Clinical trial NCT01870440: TAHOE: Intravitreal Dexamethasone Implant (Ozurdex) for Uveitic Macular Edema
Official title: TAHOE: Sustained InTravitreal DexAmetHasone Implant (Ozurdex) for Uveitic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Macular Edema
Uveitis
Keywords: Uveitis
Macular Edema
Lead sponsor: Northern California Retina Vitreous Associates
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2013-06-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Best Corrected Visual Acuity (using Early Treatment Diabetic Retinopathy Study Protocal)
timeFrame: Day 90
Secondary outcomes:
measure: Central Subfoveal Retinal Thickness
timeFrame: Day 90
measure: Central Subfoveal Retinal Thickness
timeFrame: Day 180
measure: Best Corrected Visual Acuity
timeFrame: Day 180
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
Study officials:
References:
citation: Lowder C, Belfort R Jr, Lightman S, Foster CS, Robinson MR, Schiffman RM, Li XY, Cui H, Whitcup SM; Ozurdex HURON Study Group. Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis. Arch Ophthalmol. 2011 May;129(5):545-53. doi: 10.1001/archophthalmol.2010.339. Epub 2011 Jan 10.