Effect of Ranibizumab on Malignant Conjunctival Neoplasia - Full Text View

Sponsors and Collaborators:	The New York Eye Cancer Center Genentech
Information provided by:	The New York Eye Cancer Center
ClinicalTrials.gov Identifier:	NCT00456495

Purpose

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.

Condition	Intervention	Phase
Conjunctival Neoplasms	Drug: ranibizumab	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Effect of Ranibizumab on Malignant Conjunctival Neoplasia

Resource links provided by NLM:

Genetics Home Reference related topics: retinoblastoma

MedlinePlus related topics: Cancer Eye Cancer

Drug Information available for: Ranibizumab

U.S. FDA Resources

Further study details as provided by The New York Eye Cancer Center:

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 ]

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 ]

Estimated Enrollment:	10
Study Start Date:	March 2007
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Subconjunctival injection of drug every 2 to 4 weeks

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456495

Locations

United States, New York
The New York Eye Cancer Center
New York, New York, United States, 10021

Sponsors and Collaborators

The New York Eye Cancer Center

Genentech

Investigators

Principal Investigator:

Paul T. Finger, MD

The New York Eye Cancer Center

More Information

No publications provided

Responsible Party:	Genentech ( Namrata Saroj )
Study ID Numbers:	4192s
Study First Received:	April 3, 2007
Last Updated:	May 29, 2009
ClinicalTrials.gov Identifier:	NCT00456495 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Eye Neoplasms
Eye Diseases
Conjunctival Diseases
Conjunctival Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Eye Neoplasms

Eye Diseases
Conjunctival Diseases
Conjunctival Neoplasms

ClinicalTrials.gov processed this record on September 02, 2009