Effect of Ranibizumab on Malignant Conjunctival Neoplasia - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

April 3, 2007

Last Updated Date

December 30, 2008

Start Date ^†

March 2007

Current Primary Outcome Measures ^†

To test the safety and tolerability of subconjunctival injection of ranibizumab in the treatment of malignant conjunctival neoplasia [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
using the incidence and severity of adverse events. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^†

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.

Change History

Complete list of historical versions of study NCT00456495 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

To assess the efficacy of ranibizumab treatment on malignant conjunctival neoplasia [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Evaluating tumor destruction or reduction [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
slit-lamp photography and ultrasonographic imaging [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Regression of blood vessels [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

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
Regression of blood vessels

Descriptive Information

Brief Title ^†

Effect of Ranibizumab on Malignant Conjunctival Neoplasia

Official Title ^†

Effect of Ranibizumab on Malignant Conjunctival Neoplasia

Brief 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.

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Conjunctival Neoplasms

Intervention ^†

Drug: ranibizumab

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

Estimated Completion Date

October 2009

Estimated Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Kim J Chin, OD	212-832-7297	kchin@eyecancer.com
Contact: Paul T Finger, MD	212-832-8170	pfinger@eyecancer.com

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00456495

Responsible Party

Namrata Saroj, Genentech

Secondary IDs ^††

Study Sponsor ^†

The New York Eye Cancer Center

Collaborators ^††

Genentech

Investigators ^†

Principal Investigator:

Paul T. Finger, MD

The New York Eye Cancer Center

Information Provided By

The New York Eye Cancer Center

Verification Date

April 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.