JPRN-jRCTs031180356已完成未知
Investigation of the treat-and-extend protocol with Aflibercept in combination with retinal photocoagulation in patients with diabetic macula edema(extension study) - Investigation of the T&E protocol with IVA in combination with retinal photocoagulation in DME patients(extension study)
Murata Toshinori0 个研究点目标入组 15 人开始时间: 2019年3月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
This study suggested that Treat and Extend therapy with aflibercept combined with retinal photocoagulation is a rational strategy for diabetic macular edema treatments.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20age 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Patients with type 1 or type 2 diabetes mellitus 20 years of age or older
- •2.Patients with fovea involving diabetic macular edema (judged with central subfield thickness on OCT)
- •3.Patients with reduced visual acuity associated with diabetic macular edema
- •4.Patients whose best corrected visual acuity is more than 20/320 (24 letters) by the ETDRS visual acuity test.
- •5.Patients with a central retinal thickness (CRT) of 300 um or more on the OCT retinal map (measured in mm) as an objective finding
- •6.Patients who are willing and able to visit the study site, as scheduled, and undergo scheduled examinations in this study
- •7.Patients who can provide written voluntary consent to participate in this study after receiving adequate explanation
排除标准
- •The condition of the fellow eye is worse than that of the study eye.
- •A history of vitreous surgery, including encircling buckling
- •Any retinal photocoagulation treatment within 90 days
- •Topical corticosteroid treatment within 120 days
- •Treatment with injection of any anti VEGF agent into the study eye within 90 days
- •Highly active, proliferative diabetic retinopathy in the study eye
- •A history of uveitis
- •Aphakic eyes
- •A history of any intraocular surgery in the study eye within the previous 90 days
- •It is considered difficult to improve visual acuity due to morphological changes
- •Glaucoma with poor IOP control, a history of glaucoma filtering surgery, or scheduled filtering surgery in the study eye
- •IOP of the study eye: more than 25 mmHg
- •Myopia of -8D or greater
- •Study eye is the last eye
- •Optic media in which it is difficult to obtain fundus photographs or OCT images
- •Severe systemic infections at baseline
- •Systemic anticoagulation therapy within 180
- •Poorly controlled diabetes mellitus
- •Poorly controlled hypertension
- •A history of cerebrovascular accident and/or myocardial infarction within 180 days
- •Patients on dialysis and patients with renal failure requiring dialysis
研究者
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