Clinical trial of cultured human (allogeneic) corneal endothelial cell frozen preparation AE101 (DWR-2206) for bullous keratopathy

Actualeyes Inc.0 个研究点目标入组 6 人开始时间: 待定最近更新: 2025年5月26日

试验速览

暂无简介。

•Patients diagnosed with bullous keratopathy
•Patients with best corrected visual acuity of the target eye using the ETDRS visual acuity chart of 0.3 or more in LogMAR visual acuity
•Patients whose corneal endothelial cell density in the target eye is 500 cells/mm2 or less or cannot be clearly observed using a corneal endothelial specular microscope
•Patients who are 20 years of age or older and under 80 years of age at the time of obtaining consent, and who are able to provide written consent

•Patients with hypersensitivity or a history of hypersensitivity to Rho kinase inhibitors
•Patients who are using Rho kinase inhibitor eye drops in the target eye and cannot discontinue use
•Patients with steroid-induced glaucoma or a history of glaucoma
•Patients who are judged to have difficulty maintaining a prone position for 3 hours
•Patients with hypersensitivity or a history of hypersensitivity to gentamicin
•Patients with animal (cattle) allergies
•Patients with animal (rodent) allergies
•Patients who are using hyperosmolar saline eye drops or ointment in the target eye and cannot discontinue use
•Glaucoma patients with poorly controlled intraocular pressure in the target eye
•Patients who underwent cultured human corneal endothelial cell transplantation into the target eye
•Patients whose vision is not expected to improve with the use of the investigational product
•Patients who have had intraocular surgery in the target eye within 4 weeks
•Patients with active ocular infection (bacterial, fungal, viral, etc.) in the study eye

Number of cases of adverse events

Incidence rate (%) of adverse events

Number of cases of adverse events for which a causal relationship could not be denied

Incidence rate (%) of adverse events for which a causal relationship could not be denied

未报告次要终点

发起方

Actualeyes Inc.