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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The rationale for evaluating LucentisTM (a recombinant humanized anti-human Vascular Endothelial Growth Factor (VEGF) monoclonal antibody (Fab) in patients with neovascular (wet) Age related Macular Degeneration (AMD) is based on the strong correlation between VEGF levels in aqueous and vitreous humor and active blood vessel formation. LucentisTM has been shown to maintain or improve vision in wet AMD. Since the treatments do not halt the loss of visual acuity in wet AMD, it is important to accurately measure anatomic response to treatments thereby enhancing the ability to understand patterns of response and predict the necessity for continued therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab | Experimental | Open Label use of Ranibizumab for wet age related macular degeneration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab | Drug | An open-label, study of intravitreally administered ranibizumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Central retinal thickness | To measure the mean change in central retinal thickness as measured by OCT/ SLO and Stratus OCT from Baseline to Month 12. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| change in central scotoma lesion size, density and distortion due to neovascularization | To measure the mean change in central scotoma lesion size and density as measured on OCT/ SLO microperimeter from Baseline to Month 12. To measure the mean change in the scotoma size and distortion due to neovascularization as measured on the PHP from Baseline to Month 12. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katy W Tai, CCRC | Contact | 212-979-4251 | ktai@nyee.edu |
| Name | Affiliation | Role |
|---|---|---|
| Richard B Rosen, MD | New York Eye and Ear Infirmary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Eye and Ear Infirmary | Recruiting | New York | New York | 10003 | United States |
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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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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |