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The goal of this clinical trial is to understand the safety of AXT107 injected suprachoroidally in participants with nAMD. The main question[s] it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose | Experimental | AXT107 0.125 mg/eye |
|
| Mid Dose | Experimental | AXT107 0.250 mg/eye |
|
| High Dose | Experimental | AXT107 0.500 mg/eye |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AXT107 Low Dose | Drug | Single suprachoroidal injection of AXT107 (0.125 mg/eye) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Primary Outcome Measure: 1.Safety as Assessed by change from baseline in Incidence of Adverse Events (AEs) Incidence of ocular (study eye) and systemic AEs [Time Frame: Screening to Week 40] | 40 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Central Subfield Thickness (CST) | Secondary Outcome Measures: Efficacy as Assessed by Central Subfield Thickness (CST, measured in µm) Mean change in CST assessed by spectral domain optical coherence tomography [Time Frame: Day 0 to Week 40] | 40 Weeks |
| Mean Change in Visual Function |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New England Retina Consultants | Springfield | Massachusetts | 01107 | United States | ||
| The Retina Institue |
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| AXT107 Mid Dose | Drug | Single suprachoroidal injection of AXT107 (0.250 mg/eye) |
|
|
| AXT107 High Dose | Drug | Single suprachoroidal injection of AXT107 (0.500 mg/eye) |
|
|
Secondary Outcome Measures: Visual Function as Assessed by Mean change in Best Corrected Visual Acuity (BCVA) (number of letters in Early Treatment Diabetic Retinopathy Study (EDTRS) chart) |
| Day 0 to Week 40 |
| Visual Function Subgroup Analysis | Secondary Outcome Measures: Visual Function as Assessed by Early Treatment Diabetic Retinopathy Study (EDTRS) Chart Percentage of subjects improving ≥5, ≥10, and ≥15 letters in Best Corrected Visual Acuity (BCVA) | Day 0 to Week 40 |
| St Louis |
| Missouri |
| 63128 |
| United States |
| Asheville Eye Associates | Asheville | North Carolina | 28803 | United States |
| Erie Retina Research | Erie | Pennsylvania | 16507 | United States |
| ID | Term |
|---|---|
| C000708027 | AXT107 |
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