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The objective of this clinical study is to evaluate the safety and feasibility of focal delivery of radiation for the treatment of subfoveal choroidal neovascularization (CNV) in patients with age related macular degeneration that have failed Primary Anti-VEGF therapy.
Therapeutic advances in the arena of neovascular age-related macular degeneration (AMD) have provided multiple treatment options for the disease. Radiotherapy has been studied in multiple clinical trials in the past with many studies showing a therapeutic benefit. Treatment with radiotherapy and anti-VEGF compounds is a promising approach to treating AMD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Device: NeoVista Ophthalmic System A single procedure using the NeoVista Ophthalmic System plus an injection of Lucentis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeoVista Ophthalmic System | Device | A single procedure using the NeoVioasta Ophthalmic System plus an injection of Lucentis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Parameters to be evaluated include incidence and severity of ocular adverse events identified by eye examinations, including visual acuity. Retinal thickness will also be measured, and stereo fundus photography will be reviewed. | 3 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Assessment: Preliminary efficacy will be evaluated by measuring best-corrected visual acuity (ETDRS) and AMD lesion size and leakage as assessed by fluorescein angiography at 1, 2, 3, 6, 12, 18, 24, and 36 months in the study eye. | 3 Years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey S Heier, MD | Ophthalmic Consultants of Boston | Principal Investigator |
| Jeffrey A Nau, MMS | NeoVista, Inc | Study Director |
| Michael Singer, MD | Medical Center Ophthalmology Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States | ||
| Medical Center Ophthalmology Associates |
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| San Antonio |
| Texas |
| 78240 |
| United States |