Bloodstream Absorption of Avastin and Lucentis After Injection Into the Eye

Study Overview
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Brief Summary
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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.

Detailed Description
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see above

Official Title
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Systemic Absorption of Bevacizumab and Ranibizumab in Humans Treated for Diabetic Macular Edema

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: Bevacizumab
* Drug: Ranibizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ranibizumab<br>intravitreal injection of 0.5mg ranibizumab in usual fashion | Drug: Ranibizumab<br>* Ranibizumab is a vascular endothelial growth factor inhibitor designed for ocular use<br>* Other names: Lucentis;|
| Active Comparator: Bevacizumab<br>intravitreal injection of 1.25mg bevacizumab in usual fashion | Drug: Bevacizumab<br>* Bevacizumab is an off-label but cheaper treatment for diabetic macular edema.<br>* Other names: Avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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macular edema, vascular endothelial growth factor, diabetic retinopathy