JPRN-jRCT2043220105招募中1 期
Phase I/IIa clinical study of PAL-222 targeting patients with myopic chorioretinal atrophy - PAMyCA study
Kusano Hitoshi0 个研究点目标入组 10 人开始时间: 2022年12月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
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 aged 20 years or older at the time of consent acquisition
- •(2) Patients with binocular intensity myopia (myopia of -6.0D or more) or patients with axial length (26 mm) or more equivalent to -6.0D
- •(3) Corrected characters of the test eye patients with visual acuity of less than 60 characters (equivalent to decimal visual acuity 0.32)
- •(4) 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
- •(5) Patients without active choroidal neovascularization
排除标准
- •(1) Patients with abnormal findings that pose a problem in clinical trial participation in screening tests.
- •(2) Patients with positive HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody, syphilis serum reaction
- •(3) Patients with allergies to human serum albumin antibiotics, trypsin
- •(4) Patients with eye infections
- •(5) Patients with other retinal diseases (diabetic retinopathy, hypertensive retinopathy, vascular occlusion)
- •(6) Patients with confirmed optic nerve atrophy
- •(7) Patients with glaucoma who cannot control intraocular pressure
- •(8) Patients with findings associated with myopic traction macular disease (apparent posterior macular tumor, vitreous macular traction, retinal separation, macular hole detachment, macular hole)
- •(9) Patients with atrophy in all areas of the circle within 3 papilla diameter (4.5 mm) (9.0 mm in diameter) from the fovea
- •(10) Patients with corrected visual acuity of control eye 0.08 or less
- •(11) Patients with severe blood disorders, heart failure, liver disorders, and renal disorders
- •(12) Patients diagnosed with malignant tumor within 5 years or patients requiring treatment
- •(13) Pregnant women, lactating women, patients wishing to become pregnant during the trial period
- •(14) Patients who cannot discontinue anticoagulants or antiplatelet drugs before the trial
- •(15) Patients with drug addiction or alcoholism
- •(16) Patients receiving treatment with vascular endothelial growth factor inhibitor or photodynamic therapy within 6 months prior to transplantation for test eye, or 2 months for reference eye.
- •(17) 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.
研究者
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