Suprachoroidal Administration in Subjects With Choroidal Metastasis From Breast or Lung Primary Tumors
Sponsor: Aura Biosciences
ClinicalTrials ID:NCT06643884
This open-label, dose-escalation trial evaluates the safety and tolerability of bel-sar in subjects with unilateral, unifocal choroidal metastasis from breast or lung tumors. Eligible participants must have a confirmed diagnosis. Interventions include AU-011 via suprachoroidal administration using the SCS Microinjector and laser treatment.
Patient Parameters
| Parameter | Options |
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Program Overview
The primary objective is to assess the safety and tolerability of bel-sar treatment in subjects with choroidal metastasis from breast or lung primary tumors.
Description
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 choroidal metastasis from breast or lung primary tumors.
Eligibility Criteria
Inclusion Criteria
- Have a clinical diagnosis of Choroidal Metastasis, from a histopathologically or cytologically confirmed breast or lung primary tumor.
- Have a single Choroidal Metastasis in only 1 eye, and no Choroidal Metastasis in the other eye (i.e., unilateral, unifocal Choroidal Metastasis).
Exclusion Criteria
- Active ocular infection or disease.
- Must not have evidence of a primary tumor or metastatic lesion in the brain requiring treatment with radiation therapy per the primary treating oncologist's assessment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Byers Eye Institute at Stanford University | 94303 | Palo Alto | California |
| Bascom Palmer Eye Institute | 33136 | Miami | Florida |
| Massachusetts Eye and Ear | 02114 | Boston | Massachusetts |
| Kellogg Eye Center | 48105 | Ann Arbor | Michigan |
| Cleveland Clinic, Cole Eye Institute | 44195 | Cleveland | Ohio |
| Sheilds and Sheilds, PC | 19107 | Philadelphia | Pennsylvania |
| Tennessee Retina, PC | 37203 | Nashville | Tennessee |
| Retina Consultants of Texas | 77401 | Bellaire | Texas |
| University of Washington | 98104 | Seattle | Washington |
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