JPRN-UMIN000026201尚未招募未知
Clinical research of the effect and the safety with 0.1% bromfenac sodium hydrate ophthalmic solution and 0.1% betamethasone sodium phosphate ophthalmic, otic and nasal solution in patients with diabetic macular edema - The effect and the safety with 0.1% bromfenac ophthalmic solution and 0.1% betamethasone ophthalmic solution in patients with diabetic macular edema
Diabetes Center Tokyo Womens Medical University School of Medicine0 个研究点目标入组 20 人开始时间: 2017年2月18日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
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
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •On screening (1)Topical 1)Patients with severe diabetic retinopathy or DME who need IVT injection of VEGF inhibitor, retinal photocoagulation, or vitreous surgery 2)Patients with a history of hypersensitivity against components of test drugs 3)Patients with retinochoroidal disease except for diabetic retinopathy or DME 4)Patients with uveitis 5)Patients with glaucoma 6)Patients with previous vitreous surgery 7)Patients who received retinal photocoagulation or cataract surgery within 6 months before starting administration of test drugs 8)Patients who received systemic or topical administration of steroid, IVT injection of VEGF inhibitor within 1 month, or hyperbaric oxygen therapy within 6 months before starting administration of test drugs 9)Patients with excessive myopia less than -6D 10)Patients with a history of hypersensitivity against fluorescein for fluorescent fundus angiography 11)Patients unable to tolerate OCT measurement (2)Systemic 12)Patients with cancer, severe hepatopathy ,nephropathy, cardiovascular disease, or endocrine system disease, who was judged to be inappropriate as a subject by doctor in charge 13)Pregnant, lactating, or possible pregnant woman On screening and baseline (1)Topical 14)Complete loss of ELM or IS/OS line in macular OCT tomography with the eye for effect evaluation 15)Patients with subretinal fluid in macular OCT tomography 16)Patients who has cloudy cyst with possible influence to improvement of visual acuity in macular OCT tomography (3)Other 17)Patients who was judged to be inappropriate as a subject by doctor
研究者
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