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

NCT ID: NCT01870440

Last Updated: 2015-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-02-28

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.

Conditions

Macular Edema; Uveitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ozurdex Injection

Ozurdex Intravitreal Injection (0.7 mg)

Group Type: EXPERIMENTAL

Ozurdex Intravitreal Injection (0.7 mg)

Intervention Type: DRUG

Intravitreal Injection

Interventions

Ozurdex Intravitreal Injection (0.7 mg)

Intravitreal Injection

Intervention Type: DRUG

Other Intervention Names

Ozurdex (0.7 mg)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

Northern California Retina Vitreous Associates

OTHER

Sponsor Role: lead

Responsible Party

Rahul Khurana, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northern California Retina Vitreous Associates

Mountain View, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21220619 (View on PubMed)

Other Identifiers

NCRVA-2013-Ozurdex-16.2

Identifier Type: -

Identifier Source: org_study_id