NCT00456495

Effect of Ranibizumab on Malignant Conjunctival Neoplasia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: The New York Eye Cancer Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the safety and tolerability of subconjunctival injection of ranibizumab in the treatment of malignant conjunctival neoplasia using the incidence and severity of adverse events. Our secondary objective is to assess the efficacy of ranibizumab treatment on malignant conjunctival neoplasia by evaluating tumor destruction or reduction as documented by slit-lamp photography and ultrasonographic imaging and the regression of blood vessels.

Detailed description

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.

Conditions

• Conjunctival Neoplasms

Interventions

Type	Name	Description
DRUG	ranibizumab	Subconjunctival injection of drug every 2 to 4 weeks

Timeline

• Start date: 2007-03-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2007-04-05
• Last updated: 2017-07-21
• Results posted: 2013-06-06

Locations

1 site across 1 country: United States