JPRN-jRCT2051180072进行中（未招募）2 期
Clinical trial of TK-98 on retinitis pigmentosa: A prospective, randomized, double-blind, placebo-controlled study - Clinical trial of TK-98 on retinitis pigmentosa
Ikeda Hanako0 个研究点目标入组 70 人开始时间: 2019年2月22日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
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 ot applicable（—）
- 性别
- All
入选标准
- •1)patients diagnosed with typical retinitis pigmentosa
- •2)20 years of age or older at the time of informed consent
- •3)written informed consent for inclusion in the clinical trial was obtained from the patient himself/herself
排除标准
- •1)Both eyes with any of the following conditions (a-f).
- •a)A difference of > 5.0 dB in the MD value between consecutive Humphrey 10-2 visual field tests on at least two occasions (the most recent and 4 or more visual field tests performed within the last 3 years [but not less than 1 year] are analyzed)
- •b)MD value of the Humphrey 10-2 visual field test at screening > -5.0 dB or < -25.0 dB
- •c)Opacity of the optic media, which makes it difficult to examine the fundus
- •d)Nuclear cataract (Emery-Little grade 3 or more) or posterior subcapsular cataract that has progressed within a period of one year prior to the date of informed consent
- •e)Evidence of glaucoma, optic nerve disease, or vitreoretinal disease other than that concomitant to retinitis pigmentosa
- •f)History of intraocular surgery, other than cataract surgery
- •2)Best corrected decimal visual acuity < 0.01 or MD value of the Humphrey visual field test (10-2) < -30.0 dB in either eye
- •3)Systematic administration of immunosuppressive agents, anti-cancer chemotherapy, or steroids
- •4)Oral administration of calcium channel blockers or sodium valproate
- •5)Oral administration of dark adaptation-improving drugs, or drugs or supplements including (other than as an additive) vitamin A, vitamin E, DHA, taurine, lutein, or amino acids
- •6)Use of topical isopropyl unoprostone or brimonidine tartrate
- •7)Female patient who is pregnant, lactating, has child-bearing potential (pregnancy test is carried out at screening), or has a desire for bearing a child during the period from the date of informed consent to 2 weeks after the last investigational drug administration or 2 weeks after the day of discontinuation, or who has child-bearing potential but refuses to use appropriate contraception (intrauterine contraceptive devices, pessary, or the use of a condom sheath by her partner)
- •8)Patients under treatment for critical liver, respiratory, hematologic, or neurological disorders
- •9)Patients with renal failure (serum creatinine of 2.0 mg/dL or more)
- •10)Congenital dysbolism of branched-chain amino acids
- •11)History of shock or allergy to branched-chain amino acids
- •12)Patients who have participated in other interventional clinical trials within 6 months prior to the date of informed consent
- •13)Patients determined to be inappropriate for inclusion in the clinical trial by the principal investigator or sub-investigators
研究者
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