Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The Change in Visual Acuity (Number of ETDRS Letters).
研究概览
简要总结
The purpose of this study is to test the efficacy of an 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular leakage and visual acuity for patients with recalcitrant diabetic macular edema.
详细描述
This is an open-label, Phase II comparative study of an intravitreal dexamethasone implant versus intravitreal bevacizumab (Avastin) in 20 patients with recalcitrant diabetic macular edema and prior treatment with ≥ 2 intravitreal anti-VEGF injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Presence of NPDR or PDR as confirmed by fluorescein angiography
- •Prior treatment with >= 2 intravitreal anti-VEGF injections but no treatment in last 4 weeks
- •< 0.1 LogOCT decrease in macular edema on high resolution OCT between initial visit and following treatment with >= 2 intravitreal anti-VEGF injections
- •Age 18 years or older
- •ETDRS Visual acuity between 3 and 78 letters (approximate Snellen equivalent of 20/25 to 20/800)
- •Ability to provide written informed consent
- •Capable of complying with study protocol.
排除标准
- •Intraocular injection of steroid medication within prior 3 months
- •Evidence of significant geographic atrophy on fluorescein angiography in the opinion of the treating physician
- •Concurrent ocular disease (wet AMD, significant ERM, etc) that would limit visual acuity in the opinion of the treating physician
- •Prior vitrectomy surgery
- •Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month prior to day
- •Known history of IOP elevation in response to steroid treatment in either eye that resulted in any of the following: a) = 10 mm Hg increase in IOP in response to steroid injection, or b) IOP = 25 mm Hg and required 2 or more anti-glaucoma medications to keep IOP below 21 mm Hg.
- •Patients who are pregnant.
- •Unwilling or unable to follow or comply with all study related procedures
研究组 & 干预措施
Ozurdex
Patients in this group receive Ozurdex at initial visit and at month 4
干预措施: dexamethasone intravitreal implant (Drug)
Avastin
Patients in this group receive Avastin Q1 month for 5 months.
干预措施: intravitreal bevacizumab (Drug)
结局指标
主要结局
The Change in Visual Acuity (Number of ETDRS Letters).
时间窗: 6 months
The measure the change in ETDRS letters for each treatment group from baseline to 6 months.
The Change in Central Foveal Thickness (Microns on High Resolution OCT).
时间窗: 6 months
The measure the change in central foveal thickness for each treatment group from baseline to 6 months.
次要结局
- The Change in Mean Macular Sensitivity on Microperimetry From Baseline(6 months)
- The Change in Macular Leakage on Fluorescein Angiography From Baseline(6 months)
- The Change in Mean Central Amplitude on Multi-focal ERG From Baseline.(6 months)
研究者
Ron P. Gallemore
Physician and CEO of Retina Macula Institute
Retina Macula Institute