Macular Edema, Uveitis
Conditions
Keywords
Uveitis, Macular Edema
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.
Interventions
DRUGOzurdex Intravitreal Injection (0.7 mg)
Intravitreal Injection
Sponsors
Allergan
Northern California Retina Vitreous Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best Corrected Visual Acuity (using Early Treatment Diabetic Retinopathy Study Protocal) | Day 90 |
Secondary
| Measure | Time frame |
|---|---|
| Central Subfoveal Retinal Thickness | Day 90 |
| Best Corrected Visual Acuity | Day 180 |
Countries
United States
Outcome results
None listed