JPRN-jRCT2021190021进行中（未招募）1 期
Phase I/IIa study of unoprostone release drug (URD) for safety and efficacy assessment on retinitis pigmentosa
Abe Toshiaki0 个研究点目标入组 3 人开始时间: 2020年2月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3
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) Retinitis pigmentosa patients
- •2) Available for written informed consent
- •3) Patients older than 20 years old
- •4) Patients who agree to participate in this study
- •5) Decimal visual acuities of both eyes are more than 0.1, and interocular difference in visual acuity is less than or equal to 0.21 (logMAR converted value)
- •6) Ptients with no difficulty in evaluateing the thickness of IS/OS line in fovea by optical coherence tomography
- •7) Patients with no Interocular difference in the condition of lens
- •8) Visual field measured by Goldmann perimeter V-4e is more than 5 degree at the center area of vision, and interocular difference in visual field is less than 34%
- •9) Interocular difference in the MD value measured by Humphrey perimeter (10-2 program) is less than 12 dB, and difference in the mean retinal sensitivity measured in repeating tests of visit 1 and 2 or visit 2 and 3 using Humphrey perimeter (10-2 program) is less than 3 dB, and the mean retinal sensitivity measured by Humphrey perimeter (10-2 program) is less than 30 dB (central 4 points)
排除标准
- •1) Length of eyeball is less than 21 mm or more than 27 mm
- •2) Difference in interocular length of eyeball is more than 2 mm
- •3) Patients who will have ophthalmic surgery except URD implantation/removal
- •4) Patients who had intraocular surgery within 24 weeks before URD implantation
- •5) Patients who had enucleated eye
- •6) Patients with galucoma and ocular hypertension
- •7) Patients with previous history of optic nerve disease and retinal detachment
- •8) Patients with complications of diabetic retinopathy, cone-rod dystrophy, and progressive retinal disease
- •9) Patients with complications of macular edema, cyst, epimacular membrane, and macular traction by OCT examination
- •10) Patients with intense choroid atrophy such as intense myopia and posterior staphyloma
- •11) Patients with complications of extraocular inflammation, infection, and severe dry eye
- •12) Patients with previous treatment history using isopropyl unoprostone and helenien within 12 weeks before informed consent
- •13) Patients with calcium antagonist and vitamin A within 12 weeks before informed consent
- •14) Patients who have drug allergies with ophthalmic anesthetic, fluorescein, and prostaglandin
- •15) Pregnant woman, maternal, lactating woman
- •16) Patients with complications of severe kidney disease, liver disease, cranial nerve disease, Heart disease, and malignant tumor
- •17) Patients with complications of autoimmune disease, diabetes, mental disorders, cognitive impairment, and hay fever
- •18) Patients who had other clinical trial and clinical research within 24 weeks before informed consent
- •19) Patients who have been considered inappropriate as study subjects by the investigator or sub-investigator
研究者
相似试验
招募中
3 期
To study the efficacy of extended-release Urocitra in patients with observing intact pills in fecesIRCT20191026045244N4Sobhan darou Co30
进行中（未招募）
1 期
Clinical and pharmacokinetic phase II study of one hour infusion of kahalalide F administered every week to patients with Non Small Cell Lung Cancer Stage IIIB with pleural effusion and stage IV, after first line chemotherapyon Small Cell Lung Cancer Stage IIIB and IV after first Line ChemotherapyMedDRA version: 5.0Level: LLTClassification code 10029514EUCTR2004-001253-29-ESPharmaMar SA34
已完成
1 期
Phase I/II study on the safety and efficacy of repeated administration of FIT039 transdermal patch for verrucas caused by human papilloma-virusPhase I/II study on the safety and therapeutic efficacy of repeated administration of FIT039 transdermal patch on verrucas caused by human papillomavirusJPRN-UMIN000029695Department of Dermatology, Kyoto University Hospital44
已完成
2 期
Randomized phase II study of clinical effect of ultrasonically activated coagulating shears (Harmonic scalpel) for open gastrectomy.Gastric cancerJPRN-UMIN000003303Multicenter Clinical Study Group of Osaka (MCSGO)230
已完成
1 期
Phase Ia Safety and Pharmacokinetic Study of Oral NV-196 in Patients with Solid TumoursACTRN1260600034558312