TAHOE: Sustained InTravitreal DexAmetHasone Implant (Ozurdex) for Uveitic Macular Edema
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Best Corrected Visual Acuity (using Early Treatment Diabetic Retinopathy Study Protocal)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Uveitis CME with central subfoveal thickness > 350 microns
- •non-infectious uveitis
- •Visual Acuity > 20/32
排除标准
- •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
研究组 & 干预措施
Ozurdex Injection
Ozurdex Intravitreal Injection (0.7 mg)
干预措施: Ozurdex Intravitreal Injection (0.7 mg) (Drug)
结局指标
主要结局
Best Corrected Visual Acuity (using Early Treatment Diabetic Retinopathy Study Protocal)
时间窗: Day 90
次要结局
- Central Subfoveal Retinal Thickness(Day 180)
- Best Corrected Visual Acuity(Day 180)
研究者
Rahul Khurana, M.D.
Principal Investigator
Northern California Retina Vitreous Associates