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):
Diabetic Retinopathy Clinical Research Network
ClinicalTrials.gov Identifier:
NCT01627249
First received: June 21, 2012
Last updated: November 12, 2015
Last verified: November 2015
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
No text entered.

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  
Number of Participants  
[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  
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 [2]
[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)  
OCT Central Subfield [3]
[units: Microns]
Median (Inter-Quartile Range)
  387   (310 to 483)     376   (305 to 477)     390   (310 to 493)     387   (308 to 479)  
Lens Status  
[units: participants]
       
Phakic     166     160     173     499  
Pseudophakic     58     58     45     161  
Diabetic Retinopathy Severity (ETDRS Level) [4]
[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  
Prior Focal/Grid Laser for DME [5]
[units: participants]
  80     84     80     244  
Prior Anti-VEGF for DME [6]
[units: participants]
  24     31     29     84  
Prior other treatment for DME [7]
[units: participants]
  14     12     11     37  
Prior PRP [8]
[units: participants]
  32     40     35     107  
[1] Without myocardial infarction
[2] 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.
[3] OCT = Optical Coherence Tomography
[4] 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
[5] DME = Diabetic macular edema Number of participants with prior focal/grid laser for DME in the study eye
[6] VEGF = anti vascular endothelial growth factor DME = diabetic macular edema
[7] DME = Diabetic macular edema
[8] 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


No publications provided by Diabetic Retinopathy Clinical Research Network

Publications automatically indexed to this study:

Responsible Party: Diabetic Retinopathy Clinical Research Network
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: November 12, 2015
Health Authority: United States: Food and Drug Administration