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

Phase 4

Completed

• Conditions: Uveitis; Macular Edema
• Interventions: Drug: Ozurdex Intravitreal Injection (0.7 mg)

• Registration Number: NCT01870440
• Lead Sponsor: Northern California Retina Vitreous Associates

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-24
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-06
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-09
• Last Update Posted: 2015-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ozurdex Injection	Ozurdex Intravitreal Injection (0.7 mg)	Ozurdex Intravitreal Injection (0.7 mg)

Primary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity (using Early Treatment Diabetic Retinopathy Study Protocal)	Day 90

Secondary Outcome Measures

Name	Time	Method
Central Subfoveal Retinal Thickness	Day 180
Best Corrected Visual Acuity	Day 180

Trial Locations

Locations (1)

Northern California Retina Vitreous Associates; 🇺🇸 Mountain View, California, United States