Effect of Ranibizumab on Malignant Conjunctival Neoplasia
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of Ranibizumab on Malignant Conjunctival Neoplasia|
- Number of Patients Assessed for Safety and Tolerability [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]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).
- Evaluating Tumor Destruction or Reduction [ Time Frame: 2 years ] [ Designated as safety issue: No ]To evaluate the efficacy of treatment using comparative slit lamp examinations (anterior segment and ocular adnexal exam) to evaluate tumor volume, from baseline to month 12, and 24. To report on the number of patients with improvement in tumor volume.
- Regression of Blood Vessels [ Time Frame: 2 years ] [ Designated as safety issue: No ]To evaluate the efficacy of treatment using comparative slit lamp examinations (anterior segment and ocular adnexal exam) to evaluate the number of clock hours of corneal neovascularization, from baseline to month 12, and 24. To report on the number of patients with a decrease in corneal neovascularization.
|Study Start Date:||March 2007|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Experimental: Subconjunctival ranibizumab
Patients will receive subconjunctival ranibizumab every 2-4 weeks.
Subconjunctival injection of drug every 2 to 4 weeks
Other Name: Lucentis
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00456495
|United States, New York|
|The New York Eye Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Paul T. Finger, MD||The New York Eye Cancer Center|