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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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To demonstrate the effects of Lucentis (ranibizumab), Avastin ( bevacizumab), and Eylea ( aflibercept) on the levels of naturally occurring Vascular Endothelial Growth Factor (VEGF) in the systemic circulation of Age Related Macular Degeneration patients currently treated with these medications.
To determine plasma levels of VEGF and serum Pharmacokinetic (PK) levels after varying lengths of time following intravitreal injection with Avastin, Lucentis, or Eylea in exudative macular degeneration. Patients will be tested while following a normal course of treatment in our institute. All screenings and testing will be conducted in three study visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Lucentis 4 weeks | Active Comparator | Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy. |
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| Group 2 Avastin 4 weeks | Active Comparator | Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy. |
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| Group 3 Eylea 4 weeks | Active Comparator | Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy. |
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| Group 4 Lucentis 6 weeks | Active Comparator | Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy. |
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| Group 5 Avastin 6 weeks | Active Comparator | Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in serum and plasma levels of free Vascular Endothelial Growth Factor | Serum and plasma levels of free vascular endothelial growth factor will be measured up to 8 weeks following the standard of care treatment. | up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum drug levels in nanomoles (nM) units following treatment | Serum levels of Ranibizumab, Bevacizumab, or Aflibercept will be measured up to 8 weeks following the standard of care treatment. | 8 weeks |
| Amount of fluid (cubic mm) as measured by Ocular Coherence Tomography in the contralateral eye will be correlated with systemic Vascular Endothelial Growth Factor levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ronald E. Frenkel, MD | Contact | 772.287.9000 | info@efei.com |
| Name | Affiliation | Role |
|---|---|---|
| Ronald E Frenkel, MD | East Florida Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Florida Eye Institute | Recruiting | Stuart | Florida | 34994 | United States |
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| Group 6 Eylea 6 weeks |
| Active Comparator |
Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy. |
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| Group 7 Lucentis 8 weeks | Active Comparator | Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy. |
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| Group 8 Avastin 8 weeks | Active Comparator | Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy. |
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| Group 9 Eylea 8 weeks | Active Comparator | Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy. |
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| Group 10 Control Group no treatment | Active Comparator | Blood samples will be collected from patients who are not receiving anti-VEGF treatment. |
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| Bevacizumab | Drug | Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care. |
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| Aflibercept | Drug | Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care. |
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| Ranibizumab | Drug | Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care. |
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| Bevacizumab | Drug | Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care |
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| Aflibercept | Drug | Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care |
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| Ranibizumab | Drug | Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care |
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| Bevacizumab | Drug | Drug: Bevacizumab Subjects will receive intravitreal bevacizumab as part of their routine medical care |
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| Aflibercept | Drug | Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care |
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| Control Group | Other | Control group Subjects will no previous anti-VEGF treatment |
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| 8 weeks |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| D000068258 | Bevacizumab |
| C533178 | aflibercept |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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