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The Ranibizumab for Edema of the mAcula in Diabetes-2 (READ-2) Study

This study has been completed.
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
Genentech, Inc.
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00407381
First received: December 1, 2006
Last updated: March 20, 2017
Last verified: March 2017
Results First Received: August 30, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Diabetic Macular Edema
Interventions: Drug: Ranibizumab
Procedure: Laser photocoagulation

  Participant Flow
  Hide Participant Flow

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 Only

Ranibizumab (RBZ) intravitreal injection alone

Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and pro re nata (PRN) with dosing criteria.

Laser Only

Laser photocoagulation

Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator.

Laser With Ranibizumab (RBZ)

Laser following intravitreal injection of RBZ

Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.

Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator.


Participant Flow:   Overall Study
    Ranibizumab Only   Laser Only   Laser With Ranibizumab (RBZ)
STARTED   42   42   42 
COMPLETED   39   38   40 
NOT COMPLETED   3   4   2 



  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 Only

RBZ intravitreal injection alone

Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.

Laser Only

Laser photocoagulation

Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator.

Laser With RBZ

Laser following intravitreal injection of RBZ

Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.

Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator.

Total Total of all reporting groups

Baseline Measures
   Ranibizumab Only   Laser Only   Laser With RBZ   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   42   42   126 
Age 
[Units: Years]
Mean (Full Range)
 62 
 (32 to 84) 
 62 
 (34 to 86) 
 62 
 (35 to 82) 
 62 
 (32 to 86) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      29  69.0%      23  54.8%      22  52.4%      74  58.7% 
Male      13  31.0%      19  45.2%      20  47.6%      52  41.3% 


  Outcome Measures

1.  Primary:   Mean Change in Best Corrected Visual Acuity (BCVA) at Month 6   [ 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
No text entered.


  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: Quan Dong Nguyen, MD, MSc
Organization: University of Nebraska
phone: 4025591855
e-mail: quan.nguyen@unmc.edu


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

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00407381     History of Changes
Other Study ID Numbers: NA_00005254
Study First Received: December 1, 2006
Results First Received: August 30, 2016
Last Updated: March 20, 2017