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Trial record 12 of 122 for:    regeneron AND VEGF Trap-Eye

Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Patients With Diabetic Macular Edema (VISTA DME)

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ClinicalTrials.gov Identifier: NCT01363440
Recruitment Status : Completed
First Posted : June 1, 2011
Results First Posted : April 20, 2015
Last Update Posted : May 30, 2016
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetic Macular Edema
Interventions: Drug: Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321)
Procedure: Macular Laser Photocoagulation

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants with diabetic macular edema (DME) secondary to diabetes mellitus involving the center of the macula in the study eye could participate in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 687 participants who were screened for inclusion in the study, 466 were enrolled (started) and 461 received treatment.

Reporting Groups
  Description
Macular Laser Photocoagulation Treatment (Control) Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4 Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8 Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.

Participant Flow:   Overall Study
    Macular Laser Photocoagulation Treatment (Control)   Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4   Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8
STARTED   156 [1]   156 [1]   154 [1] 
Participants Received Treatment   154 [2]   155 [2]   152 [2] 
Completed Week 52   145   146   144 
Completed Week 100   133   125   127 
COMPLETED   133 [3]   125 [3]   127 [3] 
NOT COMPLETED   23   31   27 
Adverse Event                5                4                4 
Death                3                7                5 
Withdrawal by Subject                9                11                11 
Lost to Follow-up                2                4                5 
Other                4                5                2 
[1] randomized
[2] safety analysis set (SAF)
[3] Completed Week 100



  Baseline Characteristics

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.
Baseline population analyzed using the SAF

Reporting Groups
  Description
Control Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4 Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8 Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
Total Total of all reporting groups

Baseline Measures
   Control   Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4   Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8   Total 
Overall Participants Analyzed 
[Units: Participants]
 154   155   152   461 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.7  (8.65)   62  (11.16)   63.1  (9.36)   62.2  (9.7) 
Gender 
[Units: Participants]
       
Female   69   68   73   210 
Male   85   87   79   251 


  Outcome Measures

1.  Primary:   Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF)   [ Time Frame: Baseline and Week 52 ]

2.  Secondary:   Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF   [ Time Frame: Baseline and Week 52 ]

3.  Secondary:   Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF   [ Time Frame: Baseline and Week 52 ]

4.  Secondary:   Percentage of Participants With a ≥2-step Improvement From Baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Score) as Assessed by FP (Fundus Photography) at Week 52 - LOCF   [ Time Frame: Baseline and Week 52 ]

5.  Secondary:   Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF   [ Time Frame: Baseline and Week 52 ]

6.  Secondary:   Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF   [ Time Frame: Baseline and Week 52 ]

7.  Secondary:   Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF   [ Time Frame: Baseline and Week 52 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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: Clinical Trial Management
Organization: Regeneron
phone: 914 847 7000
e-mail: clinicaltrials@regeneron.com


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

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01363440     History of Changes
Other Study ID Numbers: VGFT-OD-1009
First Submitted: May 27, 2011
First Posted: June 1, 2011
Results First Submitted: August 28, 2014
Results First Posted: April 20, 2015
Last Update Posted: May 30, 2016