Effect of Ranibizumab on Malignant Conjunctival Neoplasia

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Paul T. Finger, MD, The New York Eye Cancer Center
ClinicalTrials.gov Identifier:
NCT00456495
First received: April 3, 2007
Last updated: May 3, 2013
Last verified: May 2013
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Ranibizumab on Malignant Conjunctival Neoplasia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Patients Assessed for Safety and Tolerability [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • Evaluating Tumor Destruction or Reduction [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.

  • Regression of Blood Vessels [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 5
Study Start Date: March 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subconjunctival ranibizumab
Patients will receive subconjunctival ranibizumab every 2-4 weeks.
Drug: ranibizumab
Subconjunctival injection of drug every 2 to 4 weeks
Other Name: Lucentis

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Paul T. Finger, MD, Principal Investigator, The New York Eye Cancer Center
ClinicalTrials.gov Identifier: NCT00456495     History of Changes
Other Study ID Numbers: 4192s
Study First Received: April 3, 2007
Results First Received: April 12, 2011
Last Updated: May 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Conjunctival Neoplasms
Eye Neoplasms
Neoplasms by Site
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 21, 2014