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Sponsor Decision - Low Enrollment
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This is a prospective multicenter, group-matched study of patients with primary indeterminate lesions or choroidal melanoma who receive treatment with belzupacap sarotalocan (bel-sar; AU-011) and patients who are planned to receive standard of care (SOC) treatment with plaque radiotherapy (plaque) to compare the visual outcomes of AU-011 and plaque radiotherapy.
Up to approximately 45 patients who are planned to receive plaque radiotherapy for the treatment of IL/CM based on the expert judgment of the Investigator are planned to be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case Group | Patients with primary Choroidal Melanoma and Indeterminate Lesions who have received belzupacap sarotalocan (bel-sar; AU-011) in a previous Aura sponsored clinical trial |
| |
| Control Group | Patients who are planned to receive plaque radiotherapy for the treatment of IL/CM based on the expert judgment of the investigator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care | Other | Patients who are planned to receive plaque radiotherapy for the treatment of IL/CM based on the expert judgment of the investigator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Change from baseline in logMAR visual acuity score at 5 years. | 5 years |
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Have per the investigator's expert clinical judgment, a clinical diagnosis of primary indeterminate lesion or choroidal melanoma based on the clinical history, ophthalmic examination, fundus photography and conventional ocular ultrasound.
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Patients with primary Choroidal Melanoma and Indeterminate Lesions who are planned to receive plaque radiotherapy (Control Group) and subjects with primary Choroidal Melanoma and Indeterminate Lesions who participated in previous Aura Biosciences sponsored clinical trial. (Case Group)
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Aura Biosciences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associated Retinal Consultants, P.C. | Royal Oak | Michigan | 48073 | United States | ||
| Oregon Health & Science University Casey Eye Institute |
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| Label | URL |
|---|---|
| Related Info | View source |
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| AU-011 | Drug | Previously received |
|
|
| Portland |
| Oregon |
| 97239 |
| United States |
| Retina Consultants of Carolina, PA | Greenville | South Carolina | 29605 | United States |
| St. Thomas Health/Tennessee Retina, P.C. | Nashville | Tennessee | 37203 | United States |
| Retina Consultants of Texas | Bellaire | Texas | 77401 | United States |
| Texas Retina Associates | Dallas | Texas | 75231 | United States |
| University of Wisconsin Dept of Ophthalmology & Visual Sciences | Madison | Wisconsin | 53705 | United States |
| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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