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| ID | Type | Description | Link |
|---|---|---|---|
| FVF4384s | Other Identifier | Genentech |
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The purpose of the study is to investigate the safety and tolerability of the anti-VEGF (vascular endothelial cell growth factor) treatment, ranibizumab, in combination with proton beam irradiation for the treatment of choroidal melanoma by determining the incidence and severity of ocular adverse events. Systemic adverse events will also be evaluated. A secondary objective is to assess the efficacy of ranibizumab in reducing ocular complications that can occur after irradiation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.0 mg ranibizumab | Experimental | 1.0 mg intravitreal injection given bi-monthly for 22 months |
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| 0.5 mg ranibizumab | Experimental | 0.5 mg intravitreal injection given bi-monthly for 22 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab | Drug | Ranibizumab dose of 0.5mg or 1.0 mg will be administered intravitreally at the time of surgery for tumor localization and then bimonthly for 22 months (total of 12 injections). |
| Measure | Description | Time Frame |
|---|---|---|
| incidence and severity of ocular adverse events and systemic adverse events | 12 months and 24 months after initial treatment |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of radiation-induced complications, vision loss and eye loss | 12 months and 24 months after initial treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivana Kim, M.D. | Massachusetts Eye and Ear Infirmary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts Eye & Ear Infirmary | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| D015355 | Glaucoma, Neovascular |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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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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|
| 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 |
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |