NCT05658237进行中（未招募）不适用
Phase I/IIa Clinical Study of PAL-222 Targeting Patients With Myopic Chorioretinal Atrophy (PAMyCA)
PharmaBio Corporation1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年2月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Percentage of changes in the chorioretinal atrophic area
研究概览
简要总结
The goal of this clinical trial is to assess efficacy and safety in patients with myopic chorioretinal atrophy.
The main question it aims to answer are:
• Percentage of changes in the chorioretinal atrophic area
Participants will be implanted one sheet of PAL-222 into the subretinal space through pars plana vitrectomy.
Researchers will compare non-therapeutic eye to see if the changes is significant different.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 20 years or older at the time of consent acquisition
- •Patients with binocular intensity myopia (myopia of -6.0 diopter (D) or more) or patients with axial length (26 mm) or more equivalent to -6.0 D
- •Corrected characters of the test eye patients with visual acuity of less than 60 characters (equivalent to decimal visual acuity 0.32)
- •Patients diagnosed with binocular myopic chorioretinal atrophy and having atrophy of 1 papillary diameter (1.5 mm) or more in the area within 2 papillary diameter (3.0 mm) including the fovea centralis in the subject eye
- •Patients without active choroidal neovascularization
排除标准
- •Patients with abnormal findings that pose a problem in clinical trial participation in screening tests.
- •Patients with positive hepatitis B surface (HBs) antigen, Hepatitis C virus (HCV) antibody, Human immunodeficiency virus (HIV) antibody, Human T-lymphotropic virus type 1 (HTLV-1) antibody, syphilis serum reaction
- •Patients with allergies to human serum albumin antibiotics, trypsin
- •Patients with eye infections
- •Patients with other retinal diseases (diabetic retinopathy, hypertensive retinopathy, vascular occlusion)
- •Patients with confirmed optic nerve atrophy
- •Patients with glaucoma who cannot control intraocular pressure
- •Patients with findings associated with myopic traction macular disease (apparent posterior macular tumor, vitreous macular traction, retinal separation, macular hole detachment, macular hole)
- •Patients with atrophy in all areas of the circle within 3 papilla diameter (4.5 mm) (9.0 mm in diameter) from the fovea
- •Patients with corrected visual acuity of control eye 0.08 or less
- •Patients with severe blood disorders, heart failure, liver disorders, and renal disorders
- •Patients diagnosed with malignant tumor within 5 years or patients requiring treatment
- •Pregnant women, lactating women, patients wishing to become pregnant during the trial period
- •Patients who cannot discontinue anticoagulants or antiplatelet drugs before the trial
- •Patients with drug addiction or alcoholism
- •Patients receiving treatment with vascular endothelial growth factor inhibitor or photodynamic therapy within 4 months prior to transplantation for test eye or 2 months for reference eye.
- •Patients who underwent eye surgery (excluding lens reconstruction) within 3 months before transplantation. In the case of cataract surgery, if 7 days or more have passed since surgery and postoperative inflammation is stable, registration is possible.
结局指标
主要结局
Percentage of changes in the chorioretinal atrophic area
时间窗: Just before transplantation，after 3days and 1,2,4,8,12,16,20,24,32,40,52weeks
Assesment by the principal investigator or sub-investigator will be conducted and central committee will adjudicate the assessment.
次要结局
未报告次要终点
研究者
研究点 (1)
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