JPRN-jRCT2073180024进行中（未招募）1 期
An investigator-initiated phase I/IIa trial of subretinal injection of DVC1-0401 as neuroprotective gene therapy for retinitis pigmentosa
Ikeda Yasuhiro0 个研究点目标入组 12 人开始时间: 2019年2月22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
- 12
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
- >= 40age old 至 <= 70age old（—）
- 性别
- All
入选标准
- •1) Subjects with retinitis pigmentosa diagnosed by two or more ophthalmic specialists
- •2) 40 years and above, and 70 years or younger
- •3) The mean retinal sensitivity measured by Humphrey perimeter (10-2 program) is less than 30 dB (central 4 points)
- •4) Interocular difference in visual acuity is less than or equal to 0.21 (logMAR converted value)
- •5) Interocular difference in visual field is less than or equal to twofold (Goldmann perimeter V-4e)
- •6) Interocular difference in the MD value measured by Humphrey perimeter (10-2 program) is less than or equal to 5 dB
- •7) Interocular difference in central retinal thickness measured by optical coherence tomography is less than or equal to 50 um
- •8) No interocular difference in the structure of outer retinal layer (ellipsoid zone) observed by optical coherence tomography
- •9) In case of subjects who are followed up over three years, interocular difference in the rate of change of visual acuity (logMAR converted value) and the MD value measured by Humphrey perimeter (10-2 program) is less than or equal to twofold
- •10) Difference in the mean retinal sensitivity measured in repeating tests using Humphrey perimeter (10-2 program) within 60 days before administration is binocularly less than or equal to 3 dB. If results from first and second tests don't fulfill the above criteria, the result from third test performed within 7 days from the second test is acceptable.
- •11) No significant pigmentation in ophthalmoscopic examination
- •12) Subjects who can give consent in writing by oneself (If subjects can not read the document because of reduction in visual function, both oral consent of the subject and signature of witness are necessary.)
排除标准
- •1) HIV antibody-positive
- •2) Decimal visual acuities of both eyes are less than 0.1, or lateral or bilateral blindness
- •3) Cone-rod dystrophy
- •4) Interocular difference in the condition of lens
- •5) Co-existence of glaucoma or ocular hypertension (intraocular pressure is more than or equal to 22 mmHg)
- •6) Co-existence of uveitis or optic neuritis
- •7) Retinal or subretinal pathological change observed by fundus examination (including fluorescein fundus angiography, laser scanning fundus photography), that is independent of retinitis pigmentosa
- •8) Visual field measured by Goldmann perimeter V-4e is less than 10 degree at the center area of vision
- •9) Loss or massive structural irregularity of the layer of retinal pigment epithelium on OCT (optical coherence tomography) at the supposed site of administration
- •10) Having severe allergy or previous history
- •11) Receiving chronic hemodialysis therapy
- •12) Severe heart dysfunction or heart failure
- •13) Sever hepatic dysfunction or liver cirrhosis
- •14) Active inflammatory diseases
- •15) History of cerebral hemorrhage or infarction within 6 months before agreement
- •16) Hematopoietic disorders
- •17) Alcoholism and/or drug dependence
- •18) Female subjects with pregnant or doubt of pregnancy. Breast-feeding female.
- •19) Subjects who are diagnosed with cancer or suspected to have cancer. History of treatment of malignancies within 5 years.
- •20) Disapprove of birth control during at least 12 months after the administration
- •21) Administration of Helenien, Unoprostone, and/or Ca antagonist intended for treatment of eye disease within 30 days before agreement
- •22) Taking the antiviral drug at the registration
- •23) Plan of operation other than administration of the investigational drug during this clinical trial
- •24) Entry into other clinical trial and/or clinical study, or history of entry within 6 months before agreement
- •25) Others: Subjects who are judged to be inappropriate by principal investigator or subinvestigator
研究者
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