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The purpose of this study is to assess the efficacy and safety of single injection dose of AURN001 compared with placebo in adult participants with corneal edema secondary to corneal endothelial dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AURN001 | Experimental | Participants will receive single dose of AURN001 |
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| Placebo | Placebo Comparator | Participants will receive single dose of placebo control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination Product: AURN001 + Y-27632 | Drug | AURN001 will be injected to the anterior chamber of the eye. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who achieve a ≥ 15-letter improvement (3-line gain) from baseline in Best Corrected Visual Acuity (BCVA) at Month 6 | At Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in non-contact Central Corneal Thickness (CCT) at Month 6 | Baseline (Day 1) and At Month 6 | |
| Change from baseline in BCVA at Month 6 | Baseline (Day 1) and At Month 6 |
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Key Ocular Inclusion Criteria:
(All ocular criteria apply to the study eye unless noted otherwise)
Key Ocular Exclusion Criteria:
(All ocular criteria apply to the study eye unless noted otherwise)
Other inclusion/exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aurion Study Team | Contact | 1-857-639-4163 | ASTRA@aurionbiotech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site 2 | Recruiting | Mesa | Arizona | 85206 | United States | |
| Investigational Site 6 |
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| Placebo | Other | Placebo control will be injected to the anterior chamber of the eye. |
|
| Recruiting |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Investigational Site 9 | Recruiting | Fort Collins | Colorado | 80528 | United States |
| Investigational Site 7 | Recruiting | Atlanta | Georgia | 30339 | United States |
| Investigational Site 4 | Recruiting | Kansas City | Missouri | 64154 | United States |
| Investigational Site 11 | Recruiting | Leland | North Carolina | 28451 | United States |
| Investigational Site 5 | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
| Investigational Site 3 | Recruiting | Cynwyd | Pennsylvania | 19004 | United States |
| Investigational Site 10 | Recruiting | Plymouth Meeting | Pennsylvania | 19462 | United States |
| Investigational Site 12 | Recruiting | Ladson | South Carolina | 29456 | United States |
| Investigational Site 8 | Recruiting | San Antonio | Texas | 78209 | United States |
| Investigational Site 1 | Recruiting | Spring | Texas | 77388 | United States |
| ID | Term |
|---|---|
| D015715 | Corneal Edema |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C108830 | Y 27632 |
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