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Effect of Ranibizumab on Malignant Conjunctival Neoplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00456495
Recruitment Status : Completed
First Posted : April 5, 2007
Results First Posted : June 6, 2013
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Paul T. Finger, MD, The New York Eye Cancer Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Conjunctival Neoplasms Drug: ranibizumab Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Ranibizumab on Malignant Conjunctival Neoplasia
Study Start Date : March 2007
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Patients Assessed for Safety and Tolerability [ Time Frame: 2 years ]
    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 :
  1. Evaluating Tumor Destruction or Reduction [ Time Frame: 2 years ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456495


Locations
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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, Inc.
Investigators
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Principal Investigator: Paul T. Finger, MD The New York Eye Cancer Center
More Information
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Publications of Results:

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Responsible Party: Paul T. Finger, MD, Principal Investigator, The New York Eye Cancer Center
ClinicalTrials.gov Identifier: NCT00456495    
Other Study ID Numbers: 4192s
First Posted: April 5, 2007    Key Record Dates
Results First Posted: June 6, 2013
Last Update Posted: July 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Conjunctival Neoplasms
Neoplasms
Eye Neoplasms
Neoplasms by Site
Conjunctival Diseases
Eye Diseases
Ranibizumab
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents