JPRN-jRCTs031180210进行中（未招募）未知
Effectiveness and safety of Combination therapy of Ranibizumab and LuseOgliflozin in type 2 diabetes with diabetic Macular Edema, a parallel group comparison with the standard Treatment controlled by Glimepiride, multicenter, randomized, open-label trial - COMET Trial
Yokote Koutaro0 个研究点目标入组 60 人开始时间: 2019年3月7日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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) Patients with type 2 diabetes mellitus who are aged of 20 years or older and younger than 80 years when giving their consent
- •2) patients with diabetic macular edema which affects fovea centralis of macula lutea, and with corrected visual acuity of 0.05 or higher
- •3) patients with retina thickness of study eye measured by OCT is 350 micrometer or more at the screening test. If the retina thickness of both eyes are 350 micrometer of more, the eye with thicker retina is defined as the study eye.
- •4) patients with HbA1c of 6.5% or higher and less than 12.0% at the screening test
- •5) patients with BMI of 18.5 kg/m2 or higher at the screening test
- •6) patients with eGFR of 30 mL/min/1.73m2 or higher at the screening test
- •7) patients in whom treatment of diabetes mellitus have not been changed in 8 weeks before the screening test
- •8) patients who provide written consent form to participate in this study after full explanation of the study
排除标准
- •Patients who fall into any of the following criteria are excluded from participating in the study.
- •1)patients with type 1 diabetes mellitus
- •2)patients with history of hypersensitivity against SGLT2 inhibitor or glimepiride
- •3)patients with history of coma or precoma due to the diabetes mellitus or hypoglycemia within the 24 weeks before the screening test
- •4)Patients with severe infections, before or after surgery, or severe trauma which require insulin treatment
- •5)Patients with severe renal dysfunction (eGFR < 30mL/ min/1.73m2), or patients who undergo dialysis (including peritoneal dialysis)
- •6)Female patients who are pregnant, possibly pregnant, or planned to be pregnant or breast feeding
- •7)Patients with urinary tract infection or dehydration, or patients who are prone to urinary tract infection or dehydration
- •8)Patients with positive urinary ketone body (urine qualitative of 2+ or higher)
- •9)Patients with history of leg amputation due to leg gangrene
- •10)Patients with history of bone fracture due to osteoporosis
- •11) Patients who were treated by thiazolidine, SGLT2 inhibitors, sulfonylurea or glinide within 8 weeks before the screening test
- •12)Patients who were treated by fibrate or diuretic agents and who changed the usage or dose of them within 8 weeks before the screening test
- •13)Patients who had systemic administration of steroid within 8 weeks before the screening test
- •14)Patients with history of cerebrovascular impairment or myocardial infarction within 48 weeks before the screening test
- •15)Patients with poorly controlled hypertension (clinic blood pressure measured in sitting position is 180 mmHg of higher in systolic blood pressure or 100 mmHg or higher in diastolic blood pressure)
- •16)patients with history of retina vitreal surgery or scleral buckling
- •17)Patients with history of filtration surgery to the study eye for glaucoma treatment, or patients who are expected to require the filtration surgery in future
- •18)Patients with active proliferative diabetic retinopathy in the study eye
- •19)Patients with history of idiopathic or autoimmune uveitis in the study eye
- •20)Patients with vitreomacular traction syndrome or epi-retinal membrane in the study eye measured by slit lamp microscope or OCT, which affect the central visual acuity
- •21)Patients with iris neovessel, vitreous hemorrhage, or traction retinal detachment in the study eye
- •22)Patients with epi-retinal membrane in the study eye, which affect macular area
- •23)Patients with morphological impairment at the central area of macula lutea in the study eye, which can affect the improvement of visual acuity after the disappearance of macular edema, such as atrophy of retinal pigment epithelium, fibrogenesis or scarring under the retina, severe retina ischemia or structural hard exudate
- •24)Patients with history of cataract surgery or other intraocular surgeries to the study eye within 12 weeks before the screening test
- •25)Patients with history of laser panretinal or macular photocoagulation to the study eye within 12 weeks before the screening test
- •26)Patients with history of YAG laser posterior capsulotomy to the study eye within 4 weeks before the screening test
- •27)Patients who received steroid to the study eye or the surrounding of the study eye within 16 weeks before the screening test
- •28)Patients who received angiogenic inhibitor (pegaptanib, bevacizumab, ranibizumab, aflibercept and others) to any eyes within 12 weeks before the screening test
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