JPRN-jRCTs031180308已完成未知
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.
Kitano Shigehiko0 个研究点目标入组 20 人开始时间: 2019年3月15日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
In diabetic macular edema, no significant effect of improving retinal thickness and visual acuity in the bromfenac group was confirmed compared to the betamethasone group. Intraocular pressure increased significantly from baseline in the betamethasone group.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)Written informed consent
- •2)Patients with diabetic macular edema
- •3)Patients with HbA1c value less than 10%
- •4)Patients with visual acuity more than 0.5
- •5)Patients with 250-500 micrometer of central macular thickness
排除标准
- •1)Patients with severe diabetic retinopathy or diabetic macular edema 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 diabetic macular edema
- •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
- •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 women
- •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
- •17)Patients who was judged to be inappropriate as a subject by doctor
研究者
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