Evaluation of the effect of valproic acid for retinitis Pigmentosa

Seoul National University Hospital0 个研究点目标入组 196 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•Diagnosis of retinitis pigmentosa (RP) established by night blindness, visual field constriction, marked reduction of electroretinogram, and the clinical signs of RP in fundus examination
•-Best corrected visual acuity of 20/200 or more on a Snellen chart in at least one eye
•-Intact visual field of 5 or more as measured by the kinetic perimetry
•-Understand and sign the IRB-approved informed consent document for the study
•-Body weight: male (40 kg to 100 kg), female (40 kg to 80 kg)
•-Must be able to swallow tablets
•-Female subjects of childbearing potential must commit to practice acceptable methods of contraception

•-Pregnant women
•-Lactating mothers
•-Medical problems that make consistent follow-up over the treatment period unlikely (e.g., stroke, myocardiac infarction, malignancy) or severe systemic disease
•-Other ocular disease: retinal disease other than RP or cystoid macular edema, glaucoma, cataract worse than +2PSC or infectious corneal disease
•-Coagulation disorder or bleeding-tendency
•-Liver dysfunction
•-Renal dysfunction
•-History of pancreatitis
•-History of neurological disorders including epilepsy, history of brain injury or any organic brain disorders
•-History of mental disorders including schizophrenia, bipolar disorder, or suicidality
•-Currently receiving valproic acid or other anti-convulsants
•-Has taken one of the following drugs at least 4 weeks prior to enrollment as these drugs are specifically known to affect the progression of RP: vitamin A, lutein, omega-3 fatty acid, or any antioxidant which affect the blood flow of retina or retinal function.

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