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Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema (Protocol T)

This study has been completed.
Sponsor:
Collaborators:
National Eye Institute (NEI)
Genentech, Inc.
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT01627249
First received: June 21, 2012
Last updated: August 25, 2016
Last verified: August 2016
Results First Received: September 29, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Diabetic Macular Edema
Interventions: Drug: 2.0 mg intravitreal aflibercept
Drug: 1.25 mg intravitreal bevacizumab
Drug: 0.3 mg intravitreal 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
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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
Aflibercept 2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
Bevacizumab 1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
Ranibizumab 0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab at baseline and up to every 4 weeks using defined retreatment criteria.

Participant Flow:   Overall Study
    Aflibercept   Bevacizumab   Ranibizumab
STARTED   224   218   218 
COMPLETED   208   206   206 
NOT COMPLETED   16   12   12 
Death                3                5                3 
Withdrawal by Subject                12                6                9 
Missed Visit                1                1                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.
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Reporting Groups
  Description
Aflibercept 2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
Bevacizumab 1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
Ranibizumab 0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab at baseline and up to every 4 weeks using defined retreatment criteria.
Total Total of all reporting groups

Baseline Measures
   Aflibercept   Bevacizumab   Ranibizumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 224   218   218   660 
Age, Customized 
[Units: Years]
Mean (Standard Deviation)
 60  (10)   62  (10)   60  (11)   61  (10) 
Gender, Customized 
[Units: Participants]
       
Women   110   103   94   307 
Men   114   115   124   353 
Race/Ethnicity, Customized 
[Units: Participants]
       
White   145   139   146   430 
Black/African American   32   37   36   105 
Hispanic   37   36   30   103 
Native Hawaiian/other Pacific Islander   2   2   0   4 
American Indian/Alaskin Native   1   0   0   1 
More than one race   4   1   1   6 
Unknown/not reported   1   1   1   3 
Asian   2   2   4   8 
Diabetes Type 
[Units: Participants]
       
Type 1   22   12   16   50 
Type 2   196   205   196   597 
Uncertain   6   1   6   13 
Prior Myocardial Infarction 
[Units: Participants]
 13   14   16   43 
Prior Coronary Artery Disease [1] 
[Units: Participants]
 22   27   34   83 
[1] Without myocardial infarction
Prior Stroke 
[Units: Participants]
 8   13   10   31 
Prior Transient Ischemic attacks 
[Units: Participants]
 6   8   10   24 
Prior Hypertension 
[Units: Participants]
 177   181   175   533 
Visual Acuity Letter Score [1] 
[Units: Units on a scale]
Median (Inter-Quartile Range)
 69 
 (59 to 74) 
 69 
 (60 to 72) 
 68 
 (58 to 73) 
 69 
 (59 to 73) 
[1] Best corrected visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. Best value on the scale 97, worst 0.
OCT Central Subfield [1] 
[Units: Microns]
Median (Inter-Quartile Range)
 387 
 (310 to 483) 
 376 
 (305 to 477) 
 390 
 (310 to 493) 
 387 
 (308 to 479) 
[1] OCT = Optical Coherence Tomography
Lens Status 
[Units: Participants]
       
Phakic   166   160   173   499 
Pseudophakic   58   58   45   161 
Diabetic Retinopathy Severity (ETDRS Level) [1] 
[Units: Participants]
       
Absent of minimal NPDR   7   6   5   18 
Mild to moderately severe NPDR   150   131   145   426 
Severe NPDR   17   15   18   50 
Prior PRP; without current PDR   17   21   16   54 
Mild to moderate PDR   28   31   23   82 
High risk PDR   2   7   9   18 
Missing   3   7   2   12 
[1] ETDRS = Early Treatment Diabetic Retinopathy Study; DR = diabetic retinopathy; PDR = proliferative diabetic retinopathy, NPDR = non-proliferative diabetic retinopathy, PRP = panretinal photocoagulation Criteria are based on the ETDRS fundus photographic risk factors for the progression of diabetic retinopathy. ETDRS report no. 12. Ophthalmology 1991; 98:823-833
Prior Focal/Grid Laser for DME [1] 
[Units: Participants]
 80   84   80   244 
[1] DME = Diabetic macular edema Number of participants with prior focal/grid laser for DME in the study eye
Prior Anti-VEGF for DME [1] 
[Units: Participants]
 24   31   29   84 
[1] VEGF = anti vascular endothelial growth factor DME = diabetic macular edema
Prior other treatment for DME [1] 
[Units: Participants]
 14   12   11   37 
[1] DME = Diabetic macular edema
Prior PRP [1] 
[Units: Participants]
 32   40   35   107 
[1] PRP = panretinal photocoagulation number of participants with prior panretinal photocoagulation in the study eye


  Outcome Measures
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1.  Primary:   Overall Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year   [ Time Frame: Baseline to 1-year ]

2.  Primary:   Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score <69   [ Time Frame: Baseline to 1-year ]

3.  Primary:   Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score 78-69   [ Time Frame: Baseline to 1-year ]

4.  Secondary:   Overall Change in Optical Coherence Tomography Central Subfield Thickness   [ Time Frame: baseline to 1-year ]

5.  Secondary:   Change in Optical Coherence Tomography Central Subfield Thickness: Baseline Visual Acuity Letter Score <69   [ Time Frame: baseline to 1-year ]

6.  Secondary:   Change in Optical Coherence Tomography Central Subfield Thickness: Baseline Visual Acuity Letter Score 78-69   [ Time Frame: baseline to 1-year ]

7.  Secondary:   Overall Change in Retinal Volume   [ Time Frame: Baseline to 1-year ]

8.  Secondary:   Total Number of Injections Prior to 1 Year   [ Time Frame: Baseline to 1-year ]

9.  Secondary:   Total Number of Laser Treatments   [ Time Frame: between 24 weeks and 1 year ]

10.  Secondary:   Eyes Receiving 1 or More Alternative Treatments for DME Other Than Laser   [ Time Frame: Baseline to 1-year ]


  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: Adam Glassman
Organization: Jaeb Center for Health Research
phone: 813-975-8690
e-mail: drcrstat2@jaeb.org


Publications of Results:
Other Publications:

Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT01627249     History of Changes
Other Study ID Numbers: DRCR.net Protocol T
EY14231 ( Other Grant/Funding Number: National Eye Institute )
EY23207 ( Other Grant/Funding Number: National Eye Institute )
EY18817 ( Other Grant/Funding Number: National Eye Institute )
Study First Received: June 21, 2012
Results First Received: September 29, 2015
Last Updated: August 25, 2016
Health Authority: United States: Food and Drug Administration