Use of Ranibizumab to Treat Rubeosis in Diabetics Prior to Cataract Surgery

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Bhagat, Neelakshi, M.D., M.P.H.
ClinicalTrials.gov Identifier:
NCT01069341
First received: February 15, 2010
Last updated: September 4, 2012
Last verified: September 2012
Results First Received: July 25, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Rubeosis Iridis
Proliferative Diabetic Retinopathy
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
Subjects were recruited from the patients seen in the Ophthalmology Department at the University of Medicine and Dentistry of New Jersey.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
All Subjects With Treatment All subjects received o.5 mg of ranibizumab injections monthly for 3 months

Participant Flow:   Overall Study
    All Subjects With Treatment  
STARTED     4  
COMPLETED     3  
NOT COMPLETED     1  
Lost to Follow-up                 1  



  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
All Subjects With Treatment All subjects received o.5 mg of ranibizumab injections monthly for 3 months

Baseline Measures
    All Subjects With Treatment  
Number of Participants  
[units: participants]
  4  
Age  
[units: particpants]
 
<=18 years     0  
Between 18 and 65 years     2  
>=65 years     2  
Gender  
[units: participants]
 
Female     2  
Male     2  



  Outcome Measures
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1.  Primary:   Adverse Event (AE)   [ Time Frame: first 12 months ]

2.  Secondary:   Presence of Neovascularization of Iris (NVI) or Neovascularization of the Angle (NVA)   [ Time Frame: months 3, 7 and 12 ]

3.  Secondary:   Presence of Proliferative Diabetic Retinopathy (PDR)   [ Time Frame: at month-12 ]

4.  Secondary:   Macular Volume   [ Time Frame: at months-1,3,7, and 12 ]

5.  Secondary:   Mean Time to Re-treatment   [ Time Frame: first 12 months ]

6.  Secondary:   Mean Number of Ranibizumab Injections   [ Time Frame: first 12 months ]

7.  Secondary:   Mean Number of PRP Laser Treatments   [ Time Frame: first 12 months ]

8.  Secondary:   Mean Change in Intraocular Pressure (IOP)   [ Time Frame: at months-3,7, and 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Uncontrolled pilot study with a small sample size.


  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.


Results Point of Contact:  
Name/Title: Dr. Neelakshi Bhagat
Organization: The University of Medicine and Dentistry of New Jersey
phone: 973-972-2032
e-mail: bhagatne@umdnj.edu


No publications provided


Responsible Party: Bhagat, Neelakshi, M.D., M.P.H.
ClinicalTrials.gov Identifier: NCT01069341     History of Changes
Other Study ID Numbers: FVF 4297s
Study First Received: February 15, 2010
Results First Received: July 25, 2012
Last Updated: September 4, 2012
Health Authority: United States: Food and Drug Administration