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The primary objective is to assess the safety and tolerability of bel-sar treatment in subjects with metastases to the choroid from any primary solid tumor.
This is an open-label, dose escalation trial designed to assess safety and tolerability of 4 dose strengths and 1-2 cycles of bel-sar treatment in subjects with metastases to the choroid from any primary solid tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 80 micrograms of bel-sar | Experimental | 1 Cycle AU-011 with a dose of 80 micrograms |
|
| 140 micrograms of bel-sar | Experimental | 1 Cycle AU-011 with a dose of 140 micrograms |
|
| 200 micrograms of bel-sar with one cycle | Experimental | 1 Cycle AU-011 with a dose of 200 micrograms |
|
| 200 micrograms of bel-sar with two cycles | Experimental | 2 Cycles AU-011 with a dose of 200 micrograms |
|
| Observational | No Intervention | Subjects that meet trial inclusion, but do not meet criteria for enrollment into the bel-sar treatment cohorts, may be enrolled in this cohort. The observational cohort will not receive bel-sar treatment. | |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AU-011 | Drug | AU-011 Via Suprachoroidal Administration with laser treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in choroidal tumor thickness on B-scan ultrasonography (B-scan) 4 weeks after completion of treatment. | B-Scan Ultrasonography | 4 weeks after completion of treatment |
| Change from baseline in choroidal tumor largest basal diameter (LBD) on fundus photos 4 weeks after completion of treatment. | Fundus photos | 4 weeks after completion of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical Monitor | Contact | 617-500-8864 | clinical@aurabiosciences.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Aura Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Byers Eye Institute at Stanford University | Recruiting | Palo Alto | California | 94303 | United States | |
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| 40 micrograms of bel-sar with one cycle |
| Experimental |
1 Cycle AU-011 with a dose of 40 micrograms |
|
| 40 micrograms of bel-sar with two cycles | Experimental | 2 Cycles AU-011 with a dose of 40 micrograms |
|
| SCS Microinjector | Device | Suprachoroidal Injection Device |
|
| Laser | Device | Laser Administration |
|
| Bascom Palmer Eye Institute |
| Recruiting |
| Miami |
| Florida |
| 33136 |
| United States |
| Massachusetts Eye and Ear | Recruiting | Boston | Massachusetts | 02114 | United States |
| Kellogg Eye Center | Recruiting | Ann Arbor | Michigan | 48105 | United States |
| Mayo Clinic | Not yet recruiting | Rochester | Minnesota | 55905 | United States |
| Cleveland Clinic, Cole Eye Institute | Not yet recruiting | Cleveland | Ohio | 44195 | United States |
| Shields and Shields, PC | Not yet recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| Tennessee Retina, PC | Recruiting | Nashville | Tennessee | 37203 | United States |
| Retina Consultants of Texas | Recruiting | Bellaire | Texas | 77401 | United States |
| University of Washington | Recruiting | Seattle | Washington | 98104 | United States |
| ID | Term |
|---|---|
| D005134 | Eye Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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