Diabetic Macular Edema
Conditions
Keywords
vascular endothelial growth factor, macular edema, diabetic retinopathy
Brief summary
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.
Detailed description
see above
Interventions
DRUGBevacizumab
Bevacizumab is an off-label but cheaper treatment for diabetic macular edema.
DRUGRanibizumab
Ranibizumab is a vascular endothelial growth factor inhibitor designed for ocular use
Sponsors
The Physicians' Services Incorporated Foundation
Queen's University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients in whom anti-vascular endothelial growth factor (VEGF) therapy is indicated for the treatment of diabetic macular edema * able to return for extra clinic visits according to study schedule
Exclusion criteria
* active malignancy * previous retinal laser treatment * previous anti-VEGF therapy * previous vitrectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Concentration (Cmax) of Anti-VEGF Antibody | 1 month | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bevacizumab | 5 |
| Ranibizumab | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Ranibizumab | Bevacizumab | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Continuous | 67.9 years | 62.5 years | 65.2 years |
| Region of Enrollment Canada | 5 participants | 5 participants | 10 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
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.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab | Maximum Concentration (Cmax) of Anti-VEGF Antibody | 25.22 ng/mL | Standard Error 7.59 |
| Bevacizumab | Maximum Concentration (Cmax) of Anti-VEGF Antibody | 9.56 ng/mL | Standard Error 2.5 |