WP-0508ST Phasell/lll clinical trial

Wakamoto Pharmaceutical Co., Ltd.0 个研究点目标入组 90 人开始时间: 2013年5月30日最近更新: 2023年10月17日

试验速览

暂无简介。

•A person who satisfies all the following criteria.
•1.Type 2 diabetes / Diagnostic criteria of the Japan Diabetes Association.
•2.Macular edema associated with non-proliferative diabetic retinopathy.
•3.Best corrected visual acuity ETDRS letter score of 35 to 70 in the study.
•4.Mean central macular thickness:greater than or equql to 300 um as assessed by optical coherence
•tomography in the study eye.
•5.Intraocular pressure:less than or equal to 21 mmHg in the study eye.
•6.Provide a signed informed consent form.

•1.Ocular conditions with the following symptoms in the study eye: retinal vein occlusion, uveitis, age-related macular degeneration, pseudo-ocular ophthalmic cystoid macular edema, serous retinal detachment, hard exudate, macular ischemia of severe, macular epithelium, macular serous chorioretinopathy, iris rubeosis, high myopia, glaucoma, ocular hypertension.
•2.Active eye infection or inactive toxoplasmosis in either eye.
•3.HbA1c:greater than or equql to 10.0%, serum creatinine :greater than or equql to 2.0 mg/dL.
•4.Vitreous surgery within 52 weeks before the administration of the study drug in the study eye.
•5.Previous use of sub-Tenon or retrobulbar corticosteroids within 36 weeks before administration of the study drug in the study eye.
•6.Laser photocoagulation or intraocular surgery within 12 weeks before the administration of the study drug in the study eye.
•7.The start of administration or prescription change of insulin within 12 weeks before the administration of the study drug.
•8.Pregnant or breast-feeding women.
•9.Patients who judged that the investigator or the trial doctor is inappropriate.

发起方