Comparative Study of Initial Ozurdex (Dexamethasone Implant) Versus Avastin (Bevacizumab) in the Treatment of Macular Edema Following Central Retinal Vein Occlusion (CRVO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- The Change in Visual Acuity (Number of ETDRS Early Treatment Diabetic Retinopathy Study Letters), at Month 6 as Compared With Baseline in Each Treatment Arm
研究概览
简要总结
The purpose of this study is to compare visual improvement and total number of intraocular injections in eyes with macular edema following central retinal vein occlusion (CRVO)after initial treatment with Ozurdex (dexamethasone implant) or Avastin (bevacizumab).
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 (Participant)
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 central retinal vein occlusion (CRVO)
- •Age 18 years or older
- •ETDRS (Early Treatment Diabetic Retinopathy Study) Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/40 to 20/800
- •OCT Central foveal thickness >250 microns
- •Negative pregnancy test for women of childbearing potential
- •Ability to provide written informed consent
- •Capable of complying with study protocol
排除标准
- •History of glaucoma in the study eye with intraocular pressure >21mmHg on more than one topical medication. Combination drugs are considered more than one medication
- •History of steroid-related glaucoma (steroid response)
- •Previous intraocular injection of steroid medication within 90 days
- •Avastin (bevacizumab) or Lucentis (ranibizumab) within 60 days
- •Evidence of significant retinal ischemia on fluorescein angiography in the opinion of the treating physician
- •Previous intraocular surgery (e.g. Cataract Surgery) with in 60 days
- •Concurrent ocular disease that would limit visual acuity in the opinion of the treating physician
- •Dense cataract that precludes clinical examination and retinal imaging of the retina
- •History of allergy to dexamethasone, bevacizumab, betadine
- •Ocular or systemic conditions that may pose a threat to the health of the subject in the opinion of the treating physician
- •Unwilling or unable to follow or comply with all study related procedures
- •Current participation in another clinical medical investigation or trial or has received any investigational drug within 12 weeks prior to enrollment
研究组 & 干预措施
Group 1
Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.
干预措施: Ozurdex (Drug)
Group 1
Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.
干预措施: Avastin (Drug)
Group 2
Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.
干预措施: Avastin (Drug)
结局指标
主要结局
The Change in Visual Acuity (Number of ETDRS Early Treatment Diabetic Retinopathy Study Letters), at Month 6 as Compared With Baseline in Each Treatment Arm
时间窗: Baseline - Month 6
The change in visual acuity (number of ETDRS - Early Treatment Diabetic Retinopathy Study letters), at Month 6 as compared with baseline in each treatment arm
The Total Number of Additional Avastin Injections Following Initial Treatment in Each Treatment Arm
时间窗: Baseline - Month 6
Total Number of addiitonal Avastin injections during study- From baseline to Month 6
次要结局
- Change in Central Mean Thickness Based on OCT(Baseline to 6 Months)
研究者
Vincent. A. Deramo, M.D.
Prinicipal Investigator
Long Island Vitreoretinal Consultants