JPRN-jRCTs031210235进行中（未招募）4 期
Prospective clinical trial on the safety and efficacy of anti-VEGF treatment combined with vitrectomy for diabetic macular edema with insufficient effect of anti-VEGF treatment - Eyl/ Vit trial
Baba Takayuki0 个研究点目标入组 10 人开始时间: 2021年8月11日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •1) Japanese male and female of 20 to 80 years
- •2) DME with central involvement in the study eye
- •3) Patients with a central retinal thickness (CRT) of 400 micrometer or more after 3 consecutive injections of Eylea, or patients with a CRT increases of 30% or more within 16 weeks even if the CRT decreased to less than 400 micrometers after 3 consecutive injections of Eylea
- •In cases that both eyes meet inclusion criteria and vitrectomy is performed to both eyes, the subject is only one eye, and in principle, the eye to be operated on first is the subject eye
排除标准
- •1) New patient
- •2) Last-eye patient (one-eye blindness)
- •3) Poor glycemic control (HbA1c 9.0% or higher)
- •4) Uncontrolled hypertension (systolic blood pressure> 180 mmHg or diastolic blood pressure> 110 mmHg)
- •5) Dialysis patients or patients with severe renal dysfunction who are considering the introduction of dialysis
- •6) Patients with thickened epiretinal membrane or posterior vitreous membrane in the study eye, without retinal edema in their OCT images, with less than 10% improvement in central retinal thickness by 3 consecutive injections of anti-VEGF agents
- •7) Patients with cataracts that clearly affect visual acuity in the study eye
- •8) Patients who underwent panretinal photocoagulation within 180 days of vitrectomy in the study eye
- •9) Patients who received intraocular or periocular steroids within 120 days of vitrectomy in the study eye
- •10) Patients who underwent cataract surgery or other intraocular surgery within 90 days of vitrectomy in the study eye
- •11) Patients who have a history of filtration surgery for the treatment of glaucoma in the study eye, or who are expected to need it in the future
- •12) Patients with a history of idiopathic or autoimmune uveitis in the study eye
- •13) Patients with iris neovascularization and tractional retinal detachment in the study eye
- •14) Patients with central macular structural damage such as retinal pigment epithelial atrophy, subretinal fibrosis or scarring, severe macular ischemia or organic hard macula that interferes with visual acuity improvement after macular edema disappears in the study eye
- •15) Patients with marked fluctuations in symptoms and findings
- •16) Patients who cannot understand the contents and procedures of this study
- •17) Patients who are participating in the other research
- •18) Patients who have difficulty going to the hospital
- •19) Patients who are judged by the investigator or the investigator to be unsuitable for conducting this study safely
研究者
相似试验
尚未招募
Unknown
Investigating the efficacy and safety of a prototype ultra-low-cost insulin pump (ULCIP)Type 1 Diabetes MellitusACTRN12623001288617niversity of Canterbury6
已完成
不适用
Clinical trial for efficacy and safety related to weekly dosage regimens of methotrexateRheumatoid arthritisJPRN-UMIN000021157Yokohama Minami Kyousai Hospital120
招募中
不适用
Clinical trial for the effectiveness and safety evaluation of the plasmaib alone on non-adaptive solid cancer patientsKCT0003422Samsung Medical Center25
已完成
3 期
Clinical trial of S-Metoprolol and Telmisartan combination tablet in the treatment of hypertensioCTRI/2011/06/001819Emcure Pharmaceuticals Ltd Pune200
已完成
2 期
Clinical trial to assess the efficacy and safety of TNK-TPA in Acute Ischemic StrokeCTRI/2009/091/000251Gennova Biopharmaceuticals Limited Pune50