Effectiveness and Safety of Topical Ranibizumab for Treatment of Corneal Neovascularization (NV)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Reza Dana, MD, Massachusetts Eye & Ear Infirmary
ClinicalTrials.gov Identifier:
NCT00681889
First received: May 19, 2008
Last updated: October 10, 2012
Last verified: October 2012
Results First Received: October 10, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Corneal Neovascularization
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
Patients were recruited from the Cornea Service at the Massachusetts Eye and Ear Infirmary from April 2008 through September 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were assigned to the investigational treatment upon a full eligibility screening. Participants were not eligible if they had received investigational therapy within 60 days, received treatment with anti-VEGF agents (intraocular or systemic) within 45 days, were concurrently using systemic anti-VEGF agents amongst other criteria.

Reporting Groups
  Description
Treatment Arm

10 eyes of 9 patients will receive treatment (Ranibizumab)

Ranibizumab : 10 eyes of 9 patients will receive treatment (Ranibizumab)


Participant Flow:   Overall Study
    Treatment Arm  
STARTED     9  
COMPLETED     9  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment Arm

10 Patients will receive treatment (Ranibizumab)

Ranibizumab : 10 Patients will receive treatment (Ranibizumab)


Baseline Measures
    Treatment Arm  
Number of Participants  
[units: participants]
  9  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     5  
>=65 years     4  
Age  
[units: years]
Mean ± Standard Deviation
  57.3  ± 14.5  
Gender  
[units: participants]
 
Female     4  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     9  



  Outcome Measures

1.  Primary:   Incidence and Severity of Ocular Adverse Event   [ Time Frame: 16 Weeks ]

2.  Primary:   Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs   [ Time Frame: 16 Weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Efficacy by Comparison Size and Extent of Blood Vessels in Baseline and Follow-up Corneal Photographs   [ Time Frame: Prospective ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Efficacy by Measuring Mean Change of BCVA   [ Time Frame: Prospective ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
Further and larger studies are needed to better establish the efficacy profile of this drug and optimize its dosing and formulation.  


Results Point of Contact:  
Name/Title: Dr. Reza Dana
Organization: Massachusetts Eye and Ear Infirmary
phone: 617-573-3313
e-mail: Cornea_Research@meei.harvard.edu


No publications provided


Responsible Party: Reza Dana, MD, Massachusetts Eye & Ear Infirmary
ClinicalTrials.gov Identifier: NCT00681889     History of Changes
Other Study ID Numbers: 07-11-069, 07-11-069
Study First Received: May 19, 2008
Results First Received: October 10, 2012
Last Updated: October 10, 2012
Health Authority: United States: Food and Drug Administration