Effect of Ranibizumab on Malignant Conjunctival Neoplasia

NCT ID: NCT00456495

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2010-09-30

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.

Conditions

Conjunctival Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subconjunctival ranibizumab

Patients will receive subconjunctival ranibizumab every 2-4 weeks.

Group Type: EXPERIMENTAL

ranibizumab

Intervention Type: DRUG

Subconjunctival injection of drug every 2 to 4 weeks

Interventions

ranibizumab

Subconjunctival injection of drug every 2 to 4 weeks

Intervention Type: DRUG

Other Intervention Names

Lucentis

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

The New York Eye Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Paul T. Finger, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul T. Finger, MD

Role: PRINCIPAL_INVESTIGATOR

The New York Eye Cancer Center

Locations

The New York Eye Cancer Center

New York, New York, United States

Countries

United States

References

Finger PT, Chin KJ. Refractory squamous cell carcinoma of the conjunctiva treated with subconjunctival ranibizumab (Lucentis): a two-year study. Ophthalmic Plast Reconstr Surg. 2012 Mar-Apr;28(2):85-9. doi: 10.1097/IOP.0b013e3182392f29.

Reference Type: RESULT

PMID: 22186988 (View on PubMed)

Other Identifiers

4192s

Identifier Type: -

Identifier Source: org_study_id