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Comparable data for bevacizumab and aflibercept are lacking, as are studies comparing the systemic levels of ranibizumab, bevacizumab, and aflibercept and their relative effects on circulating vascular endothelial growth factor. In the present prospective study, the investigators evaluated serum drug levels and plasma free vascular endothelial growth factor (VEGF) levels in patients with neovascular age-related macular degeneration following intravitreal injections of ranibizumab, bevacizumab and aflibercept.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept Blood Sample Collection | Active Comparator | Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy. |
|
| Bevacizumab Blood Sample Collection | Active Comparator | Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy. |
|
| Ranibizumab Blood Sample Collection | Active Comparator | Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Sample Collection | Biological | Subjects will have their blood drawn for analysis following their first and third injections of anti-VEGF. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Pharmacokinetics Following Treatment From 1st and 3rd Doses | Maximum serum levels of ranibizumab, bevacizumab or aflibercept will be measured after the first and third injections, up to 28 days following each treatment. | Up to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Minimum Serum Levels of Free Vascular Endothelial Growth Factor From Baseline to Month 4 (One Month After Last Treatment) | Minimum serum levels of free vascular endothelial growth factor will be measured at baseline and at 4 months following treatment (one month after last treatment). | baseline and month 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert L Avery, MD | California Retina Consultants | Principal Investigator |
| Melvin D Rabena, BS | California Retina Consultants | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25001321 | Derived | Avery RL, Castellarin AA, Steinle NC, Dhoot DS, Pieramici DJ, See R, Couvillion S, Nasir MA, Rabena MD, Le K, Maia M, Visich JE. Systemic pharmacokinetics following intravitreal injections of ranibizumab, bevacizumab or aflibercept in patients with neovascular AMD. Br J Ophthalmol. 2014 Dec;98(12):1636-41. doi: 10.1136/bjophthalmol-2014-305252. Epub 2014 Jul 7. |
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patients were recruited at a single private medical clinic between May of 2012 through October 2013
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| ID | Title | Description |
|---|---|---|
| FG000 | Aflibercept | Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy. Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care. |
| FG001 | Bevacizumab | Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy. Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care. |
| FG002 | Ranibizumab | Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy. Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aflibercept | Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy. Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care. |
| BG001 | Bevacizumab |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum Pharmacokinetics Following Treatment From 1st and 3rd Doses | Maximum serum levels of ranibizumab, bevacizumab or aflibercept will be measured after the first and third injections, up to 28 days following each treatment. | Posted | Mean | Standard Deviation | nM | Up to 4 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aflibercept | Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy. Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Research | California Retina Consultants | 8059631648 | 3034 | gabe@californiaretina.com |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
| D000068258 | Bevacizumab |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Aflibercept | Drug | an intravitreal injection of Aflibercept administered three times on a monthly basis. |
|
|
| Bevacizumab | Drug | an intravitreal injection of Bevacizumab administered three times on a monthly basis. |
|
|
| Ranibizumab | Drug | an intravitreal injection of Ranibizumab administered three times on a monthly basis. |
|
|
Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy. Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care. |
| BG002 | Ranibizumab | Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy. Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Ranibizumab | Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy. Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care. |
|
|
| Secondary | Change in Minimum Serum Levels of Free Vascular Endothelial Growth Factor From Baseline to Month 4 (One Month After Last Treatment) | Minimum serum levels of free vascular endothelial growth factor will be measured at baseline and at 4 months following treatment (one month after last treatment). | Posted | Mean | 95% Confidence Interval | pg/mL | baseline and month 4 |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Bevacizumab | Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy. Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care. | 0 | 15 | 0 | 15 |
| EG002 | Ranibizumab | Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy. Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care. | 0 | 20 | 0 | 20 |
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| D013927 |
| Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
|