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This is a pilot, single-center, interventional clinical trial in which subjects will receive 16 Gy of IRay treatment and Lucentis, followed by Lucentis treatment as needed.
This study will evaluate the efficacy of IRay treatment in patients with Vascularized Pigment Epithelial Detachment (V-PED) with serous component superior to 50% of the lesion as determined by decreasing the lesion activity; by decreasing the number of Lucentis injections required during the 12 month study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iray plus Lucentis | Experimental | open label arm in which all subjects receive a single 16 gy dose of radiation plus an injection of Lucentis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iray | Radiation | The Oraya IRay stereotactic radiotherapy device will be used to deliver a 16 Gy dose of radiation to the macula. The radiotherapy will be delivered in a single session utilizing three sequential beams, each depositing 5.3 Gy at the macula through calculated scleral entry points, crossing the pars plana region of the eye, and overlapping at the same region of the macula. |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion change as measured with fluorescein angiography. | Change in the proportion of the lesion which is active at 12 months. | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Lucentis injections | Number of Lucentis injections during 12 months | Baseline and 12 months |
| Visual Acuity change | Mean change in visual acuity |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università Vita-Salute Istituto Scientifico San Raffaele | Milan | Italy |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Lucentis | Drug | Intravitreal injection of Lucentis as needed. |
|
| Baseline and 12 months |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |