Effect of Ranibizumab on Malignant Conjunctival Neoplasia

Conjunctival Neoplasms Clinical Trial

Official title:

Effect of Ranibizumab on Malignant Conjunctival Neoplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00456495
• Other study ID #: 4192s
• Status: Completed
• Phase: Phase 1
• First received: April 3, 2007
• Last updated: May 3, 2013
• Start date: March 2007
• Est. completion date: September 2010

Study information

• Verified date: May 2013
• Source: The New York Eye Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctival Neoplasms

Intervention

Drug:
• ranibizumab
Subconjunctival injection of drug every 2 to 4 weeks

Locations

Country	Name	City	State
United States	The New York Eye Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
The New York Eye Cancer Center	Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Assessed for Safety and Tolerability	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).	2 years	Yes
Secondary	Evaluating Tumor Destruction or Reduction	To evaluate the efficacy of treatment using comparative slit lamp examinations (anterior segment and ocular adnexal exam) to evaluate tumor volume, from baseline to month 12, and 24. To report on the number of patients with improvement in tumor volume.	2 years	No
Secondary	Regression of Blood Vessels	To evaluate the efficacy of treatment using comparative slit lamp examinations (anterior segment and ocular adnexal exam) to evaluate the number of clock hours of corneal neovascularization, from baseline to month 12, and 24. To report on the number of patients with a decrease in corneal neovascularization.	2 years	No