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Intravitreal Alfibercept Injection in Vision Impairment Due to DME (VIVID-DME)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01331681
First received: April 7, 2011
Last updated: August 29, 2014
Last verified: August 2014
Results First Received: August 29, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Diabetes Mellitus
Macular Edema
Interventions: Biological: VEGF Trap-Eye (BAY86-5321)
Procedure: Macular Laser Photocoagulation (Control)

  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
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 604 participants who were screened for inclusion in the study, 406 were enrolled, and 404 received treatment.

Reporting Groups
  Description
Intravitreal Aflibercept Injection 2Q4 Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
Intravitreal Aflibercept Injection 2Q8 Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
Macular Laser Photocoagulation (Control) Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.

Participant Flow:   Overall Study
    Intravitreal Aflibercept Injection 2Q4     Intravitreal Aflibercept Injection 2Q8     Macular Laser Photocoagulation (Control)  
STARTED     136 [1]   135 [1]   135 [1]
Participants Received Treatment     136 [2]   135 [2]   133 [2]
Completed Week 52     125     121     115  
Completed Week 100     115     110     105  
COMPLETED     115 [3]   110 [3]   105 [3]
NOT COMPLETED     21     25     30  
Adverse Event                 7                 8                 10  
Death                 3                 6                 0  
Lack of Efficacy                 0                 1                 1  
Withdrawal by Subject                 7                 5                 14  
Protocol Violation                 0                 1                 2  
Lost to Follow-up                 2                 4                 1  
Physician Decision                 1                 0                 2  
Therapeutic procedure required                 1                 0                 0  
[1] randomized
[2] safety population
[3] Completed Week 100



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

Baseline Measures
    Intravitreal Aflibercept Injection 2Q4     Intravitreal Aflibercept Injection 2Q8     Control     Total  
Number of Participants  
[units: participants]
  136     135     133     404  
Age  
[units: Years]
Mean ± Standard Deviation
  62.6  ± 8.6     64.2  ± 7.8     63.9  ± 8.6     63.6  ± 8.3  
Gender  
[units: Participants]
       
Female     53     47     54     154  
Male     83     88     79     250  



  Outcome Measures
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1.  Primary:   Change From Baseline in BCVA (Best Corrected Visual Acuity) 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
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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 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: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


No publications provided


Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01331681     History of Changes
Other Study ID Numbers: 91745, 2010-022364-12
Study First Received: April 7, 2011
Results First Received: August 29, 2014
Last Updated: August 29, 2014
Health Authority: Austria: Agency for Health and Food Safety
Australia: Department of Health and Ageing Therapeutic Goods Administration
Germany: Federal Institute for Drugs and Medical Devices
Japan: Pharmaceuticals and Medical Devices Agency
Italy: The Italian Medicines Agency
Spain: Spanish Agency of Medicines
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products