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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
History of Changes
Results First Received: April 12, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Conjunctival Neoplasms
Intervention: Drug: ranibizumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Five consecutive subjects were enrolled over an 18-month period in a single ophthalmic oncology center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was a single ARM in this study. Subconjunctival 0.5 mg ranibizumab was given as intervention every 2-4 weeks.

Reporting Groups
  Description
Squamous Carcinoma of Conjunctiva Subconjunctival 0.5 mg ranibizumab

Participant Flow:   Overall Study
    Squamous Carcinoma of Conjunctiva  
STARTED     5  
COMPLETED     3  
NOT COMPLETED     2  
Physician Decision                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Squamous Carcinoma of Conjunctiva Subconjunctival 0.5 mg ranibizumab

Baseline Measures
    Squamous Carcinoma of Conjunctiva  
Number of Participants  
[units: participants]
 		  5  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation 		  53  ± 11  
Gender  
[units: participants]
 		 
Female     0  
Male     5  
Region of Enrollment  
[units: participants]
 		 
United States     5  



  Outcome Measures

1.  Primary:   Number of Patients Assessed for Safety and Tolerability   [ Time Frame: 2 years ]
  Show Outcome Measure 1

2.  Secondary:   Evaluating Tumor Destruction or Reduction   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   09/2012   Safety Issue:   No

3.  Secondary:   Regression of Blood Vessels   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   09/2012   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This was a small case series involving a small number of subjects. Further investigations for dose, drug delivery and case selection are warranted.  


Results Point of Contact:  
Name/Title: Clinic Coordinator
Organization: The New York Eye Cancer Center
phone: 212-832-8170
e-mail: kchin@eyecancer.com


Publications of Results:


Responsible Party: Paul T. Finger, MD, 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