Clinical trial of corneal endothelial cell regenerative medicine for bullous keratopathy

JRCT ID: jRCT2043240040

Registered date:11/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: bullous keratopathy
• Date of first enrollment: 11/06/2024
• Target sample size: 6
• Study type: Interventional
• Intervention(s): Transplantation of cultured corneal endothelial cells

Outcome(s)

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

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Naoki Okumura