JPRN-jRCTs031180355已完成4 期
Study of Treat and Extend Regimen using Aflibercept for macular edema (CRVO-ME) associated with central retinal vein occlusion
Murata Toshinori0 个研究点目标入组 7 人开始时间: 2019年3月18日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
研究概览
简要总结
The current study was discontinued because it was judged that it would be extremely difficult to reach the planned number of patients due to the difficulty in incorporating subjects. And then, it is difficult to draw any meaningful conclusions because there were 7 cases conducted compared to the planned number of 30 cases.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 years old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) 20 years and over
- •2) Within 9 months from symptoms (onset) of visual acuity decline
- •3) Decreased visual acuity due to macular edema according to central retinal vein occlusion (decimal visual acuity is 0.7 or less)
- •4) the consent of this research
- •5) Central Subfield Retinal thickness > 300 micro meter
- •6) Possible to have an intention to conduct the inspection scheduled for visit and this research
排除标准
- •1) Binocular CRVO
- •2) Glaucoma with poor control (intraocular pressure > 25 mmHg)
- •3) High blood pressure with poor control
- •4) Decreased visual acuity due to non-CRVO-ME in the target eye (age-related macular degeneration, diabetic macular edema, diabetic retinopathy, macular forebrain, atrophy of the macula)
- •5) iris neovascularization, vitreous hemorrhage, traction retinal detachment in the target eye
- •6) Topical steroid administration within the past 180 days for the target eye
- •7) Anti-VEGF drug within the past 90 days for the target eye Intravitreal injection
- •8) Cataract surgery history within the past 90 days for the target eye
- •9) posterior capsule opening operation within the past 30 days for the target eye
- •10) All intraocular surgical history within the past 90 days for the target eye
- •11) Pan-retinal photocoagulation in the target eye
- •12) Intermediate translucers difficult to obtain fundus photographs and OCT images in the target eyes
- •13) Administration of systemic angiogenesis inhibitor within 180 days from the scheduled initial dose of aflibercept
- •14) Cerebrovascular disorder and / or myocardial infarction within 180 days from the scheduled initial dose of aflibercept15) Renal failure that may require dialysis or dialysis
- •16) Systemic diseases requiring the administration of drugs that may affect the results of this study
- •17) Patients with a history of hypersensitivity to the ingredients of this drug
- •18) Patients infected with eyes or around the eyes, or patients suspected to be infected
- •19) Patients with severe inflammation in the eye
- •20) Pregnant women or women who may be pregnant
- •21) Women who are breastfeeding
- •22) Patients who wish to have childbirth or do not want contraception during the research period
- •23) Fluorescein allergy
- •24) Participation in another trial within 30 days from the scheduled date of aflibercept's first dose
研究者
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