Three-month Outcome of Ziv-aflibercept for Diabetic Macular Edema
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 主要终点
- Proportion of visual acuity improvement using Snellen chart or equivalent
研究概览
简要总结
The purpose is to show the 3-month efficacy and safety in diabetic macular edema treated with intravitreal ziv-aflibercept.
详细描述
Multi-studies have shown that Intravitreal aflibercept (Eylea) is effective and safe in diabetic macular edema (DME) treatment and has gained FDA approval but it is expansive where ziv aflibercept (ZALTRAP) has the same molecule but with high osmilar buffer solution which is FDA approved for colon rectus cancer treatment and it is cost effective.
Studies have shown that intravitreal ziv aflibercept is safe and nontoxic despite the high osmolarity and even has short term effect in wet age related macular degeneration.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with central diabetic macular edema
- •Best corrected visual acuity is 20/25 or less
- •Central macular thickness more than 250 microns
- •Patients who are able to come for all follow-up
排除标准
- •Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- •Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
- •For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.
- •Macular edema is present that is considered to be related to ocular surgery such as cataract extraction
- •Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more
- •History of major ocular surgery (including vitrectomy, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
- •Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis
研究组 & 干预措施
Ziv aflibercept
Intravitreal ziv aflibercept 1.25 mg (0.05ml) every 4 weeks
干预措施: Ziv aflibercept (Drug)
结局指标
主要结局
Proportion of visual acuity improvement using Snellen chart or equivalent
时间窗: 3 months
次要结局
- Amount of Central macular thickness reduction in microns after ziv-aflibercept treatment(3 months)
- Amount of treatment cost in USD dollars(3 months)
- Number of eyes with retinal toxicity after ziv aflibercept treatment(3 months)
研究者
Ameen Marashi
MD
Marashi Eye Clinic