Conditions: Diabetic Macular Edema
Keywords: vascular endothelial growth factor macular edema diabetic retinopathy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 10
Healthy volunteers: no

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

Arms:
arm 1: intravitreal injection of 0.5mg ranibizumab in usual fashion arm 2: intravitreal injection of 1.25mg bevacizumab in usual fashion

Interventions: intervention 1: Bevacizumab intervention 2: Ranibizumab
Intervention descriptions: intervention 1: Bevacizumab is an off-label but cheaper treatment for diabetic macular edema. intervention 2: Ranibizumab is a vascular endothelial growth factor inhibitor designed for ocular use

Protocol document: