Effect of Ranibizumab on Malignant Conjunctival Neoplasia
Ranibizumab is a recently approved vascular endothelial growth factor (VEGF) inhibitor shown
to be effective in treating exudative macular degeneration. Its analog, Avastin has also
been employed to treat macular edema, proliferative diabetic retinopathy and wet age related
macular degeneration. Ranibizumab binds to and inhibits vascular endothelial growth factor
A (VEGF-A), which has been shown to cause neovascularization and leakage in models of ocular
angiogenesis. Binding to VEGF-A prevents ranibizumab's interaction with VEGFR-1 and -2
receptors on the surface of endothelial cells, thereby reducing proliferation, vascular
leakage, and angiogenesis.
Given that conjunctival tumors require the formation of new blood vessels to supply the
proliferating cells, we propose a study to evaluate the effect of subconjunctival
ranibizumab as a primary intervention in patients with conjunctival tumors.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients Assessed for Safety and Tolerability
To test the safety and tolerability of subconjunctival injection of ranibizumab in the treatment of malignant conjunctival neoplasia - using comparative slit lamp examination [anterior segment and ocular adnexal examination for adverse events (eg abrasion, melting), visual acuity (number of patients with decrease in visual acuity), and blood pressure at each visit (number of patients with increased blood pressure from baseline), and monthly urinalyis (number of patients with abnormal protein level in urine).
Paul T. Finger, MD
The New York Eye Cancer Center
United States: Food and Drug Administration
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