Exploratory, Single-arm, Single-center, Investigator-initiated Clinical Trial to Evaluate Safety and Efficacy of Subretinal Implantation of OUH-MU001 Using OUH-MU Injector in Patients with Retinitis Pigmentosa (OUReP001)

未提供0 个研究点目标入组 3 人开始时间: 待定

适应症

试验速览

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•The patient has been diagnosed with retinitis pigmentosa.
•There is no corneal opacity in the eye, and the visual acuity is light perception.
•The visual acuity of the fellow eye is diagnosed as light perception, hand movement or counting fingers.
•The retinal imaging of the eye by optical coherence tomography (OCT) demonstrates preservation of two retinal layers, namely the nerve fiber layer and the inner plexiform layer.
•Cataract surgery in the study eye was performed at least two weeks prior to the screening.
•The patient has cognitive capacity.
•Written informed consent to participate in this clinical trial has been obtained.
•It has been determined that the observations and examinations specified in the protocol can be performed.

•The study eye has other ocular diseases except for retinitis pigmentosa.
•(1) Glaucoma
•(2) Optic nerve atrophy
•(3) Corneal opacity
•(4) Acute ocular infection
•There is a history of retinal detachment surgery in the study eye, except for laser treatment for retinal tears.
•The fundus cannot be visualized due to cataract in the study eye.
•Cataract surgery was performed within two weeks prior to the start of screening.
•The investigator judges that there is a history of drug allergy.
•ECOG Performance Status is 3 or higher.
•The patient has serious comorbidities such as hepatic, renal, cardiac, pulmonary, hematologic, metabolic, or psychiatric disorders.
•The patient is pregnant, breastfeeding, possibly pregnant, intends to become pregnant during the study period, or cannot agree to contraception during the study period.
•The patient is participating in another clinical trial or interventional clinical study, or less than three months have passed since completion of follow-up for such a trial or study.
•The investigator judges the patient to be unsuitable for enrollment from social or ethical perspectives.

发起方

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