A Clinical Study that will Evaluate the Safety and Efficacy of Subretinal Administration of a Suspension of iPS cell-derived Retinal Pigment Epithelial Cells in Patients with Retinal Pigment Epithelium Tear

JRCT ID: jRCT2073230077

Registered date:18/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: retinal pigment epithelium tear
• Date of first enrollment: 18/10/2023
• Target sample size: 21
• Study type: Interventional
• Intervention(s): HLCR011 will be administered subretinally as a single dose to the study eyes

Outcome(s)

• Primary Outcome: Number and proportion of subjects with adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

The subjects who fulfill the following criteria will be included in the study.
1.RPE tear (the longest diameter greater than 1 disc diameter) secondary to age-related macular degeneration or other retinal diseases, or idiopathic confirmed in the macular region by fundus photography (including spontaneous fluorescence) and OCT in the study eye
2.Age of 18 years or older at the time of informed consent
3.RPE tear confirmed within 6 months before informed consent
4.BCVA of >=24 and =<78 letters using the ETDRS chart in the study eye at screening and baseline
5.Women of childbearing potential who have a negative (urine) pregnancy test at screening.
6.Patients who agree to use appropriate contraception during the study period to prevent pregnancy in them or their female partners if the patients or their female partners are of childbearing potential

Exclude criteria

The subjects who meet any of the following criteria will be excluded from the study.
1.Patients with choroidal neovascularization that is attributable to other causes, such as high myopia (spherical equivalent=<-8 diopter or axial length >=26 mm) in the study eye
2.A history of vitreous surgery for macular lesions in the study eye
3.Macular hole in the study eye
4.Macular lesions that may restrict visual acuity or visual field in the study eye (e.g., significant epiretinal membrane, advanced glaucoma, except for age-related macular degeneration and retinal pigment epithelium tear)
5.Patients with poorly controlled systemic diseases
6.Women who are pregnant, may be pregnant, or are lactating
7.A history of allergy or hypersensitivity to study procedures/medications except for anesthetics, antiseptics and mydriatics which can be replaced with others
8.Patients considered by the Investigator to be inappropriate as subjects of this study

Related Information

• Primary Sponsor: Bando Kiyoko