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Use of Ranibizumab With Mitomycin C During Trabeculectomy (OCTOPUS)

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00661583
First received: April 15, 2008
Last updated: August 19, 2016
Last verified: August 2016
Results First Received: July 1, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Glaucoma
Interventions: Drug: Ranibizumab
Drug: Ranibizumab and MMC
Drug: MMC

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ranibizumab Alone

Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)

Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed

Ranibizumab and MMC

Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)

Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy

MMC Alone

MMC therapy alone (n=10)

MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy.


Participant Flow:   Overall Study
    Ranibizumab Alone   Ranibizumab and MMC   MMC Alone
STARTED   10   10   10 
COMPLETED   10   10   10 
NOT COMPLETED   0   0   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
Ranibizumab Alone

Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)

Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed

Ranibizumab and MMC

Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)

Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy

MMC Alone

MMC therapy alone (n=10)

MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy.

Total Total of all reporting groups

Baseline Measures
   Ranibizumab Alone   Ranibizumab and MMC   MMC Alone   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   10   30 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   10   10   10   30 
>=65 years   0   0   0   0 
Gender 
[Units: Participants]
       
Female   6   3   2   11 
Male   4   7   8   19 
Region of Enrollment 
[Units: Participants]
       
United States   10   10   10   30 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Assessment of Ocular Adverse Events   [ Time Frame: 6 months ]

2.  Secondary:   Percent of Subjects With a Qualified Success and Viable Bleb at 6 Months.   [ Time Frame: 6 months ]

3.  Secondary:   Mean Change in in Intraocular Pressure.   [ Time Frame: 6 months ]

4.  Secondary:   Mean Change in Visual Acuity   [ Time Frame: 6 months ]


  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
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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.


Results Point of Contact:  
Name/Title: Dr.Malik Kahook
Organization: University of Colorado Denver
phone: 720-848-2020
e-mail: malik.kahook@ucdenver.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00661583     History of Changes
Other Study ID Numbers: 07-0921
Study First Received: April 15, 2008
Results First Received: July 1, 2016
Last Updated: August 19, 2016