Effect of Ranibizumab on Malignant Conjunctival Neoplasia

The New York Eye Cancer Center

Status and phase

Completed

Phase 1

Conditions

Conjunctival Neoplasms

Treatments

Drug: ranibizumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00456495

4192s

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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