Effect of Ranibizumab on Malignant Conjunctival Neoplasia
21 Years
N/A
Both
Conjunctival Neoplasms
Trial Information
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.
Inclusion Criteria:
- Ability to provide written informed consent and comply with study assessments for the
full duration of the study
- Age > 21 years
- Tumors whose treatment with standard therapy would cause significant visual morbidity
- Diagnosis of biopsy proven malignant conjunctival neoplasia and are
- Recurrent disease
- Multi-focal disease
- Diffuse disease
Exclusion Criteria:
- Extension of tumor into eye or orbit.
- Regional spread or metastatic disease
- Pregnancy (positive pregnancy test) or lactation.
- Premenopausal women not using adequate contraception. The following are considered
effective means of contraception: surgical sterilization or use of oral
contraceptives, barrier contraception with either a condom or diaphragm in
conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- Current infection or inflammation in either eye
- Any other condition that the investigator believes would pose a significant hazard to
the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Patients Assessed for Safety and Tolerability
Outcome Description:
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).
Outcome Time Frame:
2 years
Safety Issue:
Yes
Principal Investigator
Paul T. Finger, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
The New York Eye Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
4192s
NCT ID:
NCT00456495
Start Date:
March 2007
Completion Date:
September 2010
Related Keywords:
- Conjunctival Neoplasms
- Neoplasms
- Conjunctival Neoplasms
Name | Location |
|---|---|
| The New York Eye Cancer Center | New York, New York 10021 |
