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

Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01870440
• Other study ID #: NCRVA-2013-Ozurdex-16.2
• Status: Completed
• Phase: Phase 4
• First received: May 24, 2013
• Last updated: March 9, 2015
• Start date: May 2013
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Northern California Retina Vitreous Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Uveitis

Intervention

Drug:
• Ozurdex Intravitreal Injection (0.7 mg)
Intravitreal Injection

Locations

Country	Name	City	State
United States	Northern California Retina Vitreous Associates	Mountain View	California

Sponsors (2)

Lead Sponsor	Collaborator
Northern California Retina Vitreous Associates	Allergan

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Corrected Visual Acuity (using Early Treatment Diabetic Retinopathy Study Protocal)		Day 90	No
Secondary	Central Subfoveal Retinal Thickness		Day 90	No
Secondary	Central Subfoveal Retinal Thickness		Day 180	No
Secondary	Best Corrected Visual Acuity		Day 180	No