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| Name | Class |
|---|---|
| The Physicians' Services Incorporated Foundation | OTHER |
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Currently, two similar medications are available for injection into the eye to treat a variety of eye diseases. These medications are called ranibizumab (Lucentis) and bevacizumab (Avastin). They both have a similar mechanism of action and work equally well, however only ranibizumab was designed for use in the eye. It is significantly more expensive per injection than bevacizumab (by a factor of roughly 40x).
In published studies trends have been noted towards an increased rate of systemic side effects such as heart attacks and strokes. This is presumably due to absorption of the drug(s) from the eye into the bloodstream, however this has never been shown before. The purpose of the investigators study was to compare the bloodstream levels of bevacizumab and ranibizumab at various time points after injection into the eye. This required the creation of a sophisticated assay to measure blood levels of the drugs.
see above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab | Active Comparator | intravitreal injection of 0.5mg ranibizumab in usual fashion |
|
| Bevacizumab | Active Comparator | intravitreal injection of 1.25mg bevacizumab in usual fashion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab is an off-label but cheaper treatment for diabetic macular edema. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration (Cmax) of Anti-VEGF Antibody | The serum concentrations of anti-VEGF antibody (bevacizumab or ranibizumab) will be measured pre-injection as well as at various time points after injection (1 day, 1 week, 2 weeks, 1 month). These time points are selected based on previously completed animal studies. The Cmax will be compared between bevacizumab and ranibizumab. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanjay Sharma, MD MBA MSc FRCSC | Department of Ophthalmology, Queen's University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hotel Dieu Hospital | Kingston | Ontario | K7L 5G2 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranibizumab | intravitreal injection of 0.5mg ranibizumab in usual fashion Ranibizumab: Ranibizumab is a vascular endothelial growth factor inhibitor designed for ocular use |
| FG001 | Bevacizumab | intravitreal injection of 1.25mg bevacizumab in usual fashion Bevacizumab: Bevacizumab is an off-label but cheaper treatment for diabetic macular edema. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab | |
| BG001 | Ranibizumab | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Maximum Concentration (Cmax) of Anti-VEGF Antibody | The serum concentrations of anti-VEGF antibody (bevacizumab or ranibizumab) will be measured pre-injection as well as at various time points after injection (1 day, 1 week, 2 weeks, 1 month). These time points are selected based on previously completed animal studies. The Cmax will be compared between bevacizumab and ranibizumab. | Posted | Mean | Standard Error | ng/mL | 1 month |
|
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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 | Ranibizumab | intravitreal injection of 0.5mg ranibizumab in usual fashion Ranibizumab: Ranibizumab is a vascular endothelial growth factor inhibitor designed for ocular use |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sanjay Sharma | Queen's University Department of Ophthalmology | 613-544-3400 | 2227 | sanjay_sharma60@hotmail.com |
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Ranibizumab | Drug | Ranibizumab is a vascular endothelial growth factor inhibitor designed for ocular use |
|
|
Total of all reporting groups
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Bevacizumab | intravitreal injection of 1.25mg bevacizumab in usual fashion Bevacizumab: Bevacizumab is an off-label but cheaper treatment for diabetic macular edema. | 0 | 5 | 0 | 5 |
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| D003925 |
| Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |