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

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northern California Retina Vitreous Associates
• Collaborator: Allergan
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

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