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

Clinical trial of corneal endothelial cell regenerative medicine for bullous keratopathy

6

Bullous keratopathy patients

All six cases completed the 48-week observation period.

None

Under analysis

No serious adverse events or adverse events were observed for which a causal relationship with the investigational product, AE101, a frozen preparation of cultured human (allogeneic) corneal endothelial cells, could not be ruled out.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2043240040

Naoki Okumura

Actualeyes Inc.

Room 314, D-egg, 1 Koudojizoya, Kyotanabe-shi, Kyoto 610-0332, Japan

naoki.okumura@actualeyes.co.jp

Yasushi Matsuoka

Actualeyes Inc.

Room 314, D-egg, 1 Koudojizoya, Kyotanabe-shi, Kyoto 610-0332, Japan

+81-774-66-1601

yasushi.matsuoka@actualeyes.co.jp

Complete

June. 11, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1) Patients diagnosed with bullous keratopathy
2) 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
3) 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
4) 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

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

Both

bullous keratopathy

Transplantation of cultured corneal endothelial cells

bollous keratopathy

C11

E04

Number of cases and incidence rate (%) of adverse events and adverse events for which a causal relationship could not be denied

1) Safety evaluation items
2) Number of cases and incidence rate of significant adverse events (%)
3) Occurrence of product defects
4) Efficacy endpoints
- Whether or not there is improvement in visual acuity (a decrease of 0.2 or more in LogMAR visual acuity) 24 weeks after implantation of the investigational product
- Changes in best corrected visual acuity over time
- Changes in corneal thickness over time
- Changes in corneal endothelial cell density over time

+81-52-251-6571

Mar. 25, 2024

+81-47-322-0151

Mar. 25, 2024

none