A Study Evaluating Dosing Regimens for Treatment With Intravitreal Ranibizumab Injections in Subjects With Macular Edema Following Retinal Vein Occlusion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01277302
First received: January 13, 2011
Last updated: March 27, 2014
Last verified: March 2014
Results First Received: October 17, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Macular Edema
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
No text entered.

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
Ranibizumab 0.5 mg Monthly - Randomized Subjects Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
Ranibizumab 0.5 mg PRN - Randomized Subjects Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
Ranibizumab 0.5 mg Monthly - Non-randomized Subjects Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.

Participant Flow for 2 periods

Period 1:   7-Month Fixed Treatment Period
    Ranibizumab 0.5 mg Monthly - Randomized Subjects     Ranibizumab 0.5 mg PRN - Randomized Subjects     Ranibizumab 0.5 mg Monthly - Non-randomized Subjects  
STARTED     85     86     31  
COMPLETED     85     86     19  
NOT COMPLETED     0     0     12  
Subject Decision to Withdraw                 0                 0                 8  
Lost to Follow-up                 0                 0                 2  
Subject Required Other Drug Therapy                 0                 0                 1  
Subject Non-compliance                 0                 0                 1  

Period 2:   8-Month Alternate Dose Regimen Period
    Ranibizumab 0.5 mg Monthly - Randomized Subjects     Ranibizumab 0.5 mg PRN - Randomized Subjects     Ranibizumab 0.5 mg Monthly - Non-randomized Subjects  
STARTED     85     86     19  
COMPLETED     80     82     13  
NOT COMPLETED     5     4     6  
Death                 0                 1                 0  
Lost to Follow-up                 1                 1                 3  
Subject Decision to Withdraw                 3                 0                 1  
Subject Non-compliance                 0                 2                 1  
Relocation                 1                 0                 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.
Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study.

Reporting Groups
  Description
Ranibizumab 0.5 mg Monthly - Randomized Subjects Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
Ranibizumab 0.5 mg PRN - Randomized Subjects Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
Ranibizumab 0.5 mg Monthly - Non-randomized Subjects Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
Total Total of all reporting groups

Baseline Measures
    Ranibizumab 0.5 mg Monthly - Randomized Subjects     Ranibizumab 0.5 mg PRN - Randomized Subjects     Ranibizumab 0.5 mg Monthly - Non-randomized Subjects     Total  
Number of Participants  
[units: participants]
  85     86     31     202  
Age  
[units: years]
Mean ± Standard Deviation
  67.3  ± 12.1     65.2  ± 12.8     66.3  ± 12.3     66.3  ± 12.4  
Gender  
[units: participants]
       
Female     38     37     9     84  
Male     47     49     22     118  



  Outcome Measures
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1.  Primary:   Trend of Change From Baseline in the Best Corrected Visual Acuity (BCVA) Scores From Month 7 to Month 15   [ Time Frame: Baseline to Month 15 ]

2.  Secondary:   Visual Acuity Change From Previous Month During the Alternate Dose Regimen Period in Subjects Who Met the VA-OCT Stability Criteria at the Previous Month   [ Time Frame: Month 7 through Month 15 ]

3.  Secondary:   Percentage of Participants Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline   [ Time Frame: Month 7 to Month 15 ]

4.  Secondary:   Percentage of Participants With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better   [ Time Frame: Month 7 to Month 15 ]

5.  Secondary:   Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score   [ Time Frame: Month 1 to Month 15 ]

6.  Secondary:   Percentage of Participants Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline   [ Time Frame: Month 7 to Month 15 ]

7.  Secondary:   Percentage of Participants With a Central Foveal Thickness of ≤ 300 µm   [ Time Frame: Month 7 to Month 15 ]

8.  Secondary:   Mean Change From Baseline in Central Foveal Thickness   [ Time Frame: Month 1 to Month 15 ]

9.  Secondary:   Percentage of Participants With Intraretinal Edema   [ Time Frame: Month 7 to Month 15 ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Genentech, Inc.
phone: 800 821-8590


No publications provided


Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01277302     History of Changes
Other Study ID Numbers: FVF4967g, ML01296
Study First Received: January 13, 2011
Results First Received: October 17, 2013
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration