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This is a prospective, multi-site, safety and feasibility study of the SalutarisMD SMD-DA system for retrobulbar minimally invasive episcleral brachytherapy device in patients receiving and not responding to anti-VEGF therapy for nAMD. The trial will be open label and non-randomized. The study intervention is a one-time intervention and requires no alteration to the standard of care during the follow-up period.
Subjects will receive a single brachytherapy treatment and 36 months of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| episcleral brachytherapy | Experimental | single fraction of 24 Gy Strontium90 episcleral brachytherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| episcleral brachytherapy | Radiation | The study intervention is an outpatient, ambulatory procedure performed under local anesthesia with anesthesia assist. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the study intervention | Adverse event assessment | 26 weeks |
| Tolerability of the study intervention | Subject pain score during procedure | During procedure |
| Feasibility of the study intervention | Investigator ability to place the device and deliver a therapeutic dose | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Consultants of Hawaii | ‘Aiea | Hawaii | 96701 | United States | ||
| University Retina |
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| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
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| ID | Term |
|---|---|
| C000615490 | Strontium-90 |
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|
| Oak Forest |
| Illinois |
| 60452 |
| United States |
| D008679 |
| Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |