Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the safety and efficacy of cryopreserved AURN001 in patients with corneal edema secondary to endothelial dysfunction.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Other | Endothelial polishing zone 1 (low) |
|
| Arm 2 | Other | Endothelial polishing zone 2 (medium) |
|
| Arm 3 | Other | Endothelial polishing zone 3 (high) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryopreserved AURN001 | Combination Product | Corneal Endothelial Cells and Y27632 |
|
| Measure | Description | Time Frame |
|---|---|---|
| BCVA - 15-letter improvement (3-line gain) | Response, defined as a ≥15-letter improvement (3-line gain) from baseline in best-corrected visual acuity (BCVA) | Month 6 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Manager, OD | Aurion Biotech | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aurion Biotech site | San Salvador | El Salvador |
Not provided
| ID | Term |
|---|---|
| D015715 | Corneal Edema |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided