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A Phase I/II Study of Evaluate the Safety and Efficacy of HLCR011 in Patients with Retinal Pigment Epithelium Tear

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

Bando Kiyoko

Sumitomo Pharma Co., Ltd.

6-8, Doshomachi 2-chome, Chuo-ku, Osaka, Osaka 541-0045, Japan

cr@sumitomo-pharma.co.jp

Product information center

Sumitomo Pharma Co., Ltd.

6-8, Doshomachi 2-chome, Chuo-ku, Osaka, Osaka 541-0045, Japan

+81-120-034-389

cc@sumitomo-pharma.co.jp

Recruiting

Oct. 18, 2023

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

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 neovascular age-related macular degeneration or other retinal diseases (regardless of the cause) 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. (Part 1) RPE tear confirmed within 21 months before informed consent
(Part 2) RPE tear confirmed within 9 months before informed consent
4. (Part 1) BCVA of >=1and =<78 letters using the ETDRS chart in the study eye at screening and baseline
(Part 2) BCVA of >=20 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

The subjects who meet any of the following criteria will be excluded from the study.
1. Patients with neovascularization that is attributable to causes other than neovascular age-related macular degeneration, 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 neovascular 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

Both

retinal pigment epithelium tear

HLCR011 will be administered subretinally as a single dose to the study eyes

Number and proportion of subjects with adverse events

+81-92-641-1151

Aug. 24, 2023

No

none