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Vascular Endothelial Growth Factor VEGF Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration(AMD) (VIEW1)

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00509795
First received: July 31, 2007
Last updated: December 20, 2012
Last verified: December 2012
Results First Received: December 16, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Macular Degeneration
Interventions: Biological: ranibizumab
Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)

  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
The study was conducted at 164 sites in the United States and Canada. Recruitment period: 02 Aug 2007 to 15 Sep 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2063 patients were screened, 1217 randomized, and 1215 included in the Safety Analysis Set (SAF). The Full Analysis Set (FAS) included 1210 patients with at least 1 post-baseline assessment. The Per Protocol Set (PPS) included 1089 patients who received ≥ 9 doses of study drug and attended ≥ 9 scheduled visits during the first year.

Reporting Groups
  Description
Ranibizumab 0.5mg Q4 Patients received a 0.5mg dose of ranibizumab via intravitreal (IVT) injection every 4 weeks for the first year.
IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4 Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8 Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and received sham injections at interim monthly visits.

Participant Flow:   Overall Study
    Ranibizumab 0.5mg Q4     IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4     IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4     IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8  
STARTED     306     304     304     303  
Patients Received Treatment (SAF)     304     304     304     303  
Full Analysis Set (FAS) Population     304     304     301     301  
Per Protocol Set (PPS) Population     269     285     270     265  
COMPLETED     284     293     277     276  
NOT COMPLETED     22     11     27     27  
Adverse Event                 4                 3                 5                 4  
Death                 3                 1                 2                 7  
Lack of Efficacy                 0                 0                 2                 2  
Lost to Follow-up                 1                 2                 4                 4  
OTHER                 1                 0                 4                 1  
Protocol Violation                 3                 0                 3                 1  
Withdrawal by Subject                 10                 5                 7                 8  



  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 0.5mg Q4 Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4 Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8 Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
Total Total of all reporting groups

Baseline Measures
    Ranibizumab 0.5mg Q4     IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4     IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4     IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8     Total  
Number of Participants  
[units: participants]
  304     304     304     303     1215  
Age [1]
[units: years]
Mean ± Standard Deviation
  78.2  ± 7.59     77.7  ± 7.93     78.3  ± 8.10     77.9  ± 8.39     78.0  ± 8.00  
Gender  
[units: patients]
         
Female     172     194     169     179     714  
Male     132     110     135     124     501  
Ethnicity (NIH/OMB) [1]
[units: patients]
         
Hispanic or Latino     7     11     11     12     41  
Not Hispanic or Latino     297     293     293     291     1174  
Unknown or Not Reported     0     0     0     0     0  
Race (NIH/OMB) [1]
[units: patients]
         
American Indian or Alaska Native     2     0     2     1     5  
Asian     0     3     5     4     12  
Native Hawaiian or Other Pacific Islander     1     0     0     1     2  
Black or African American     1     1     0     1     3  
White     296     295     294     289     1174  
More than one race     0     0     0     1     1  
Unknown or Not Reported     4     5     3     6     18  
Baseline National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) total score [2]
[units: scores on a scale]
Mean ± Standard Deviation
  71.7  ± 17.29     70.4  ± 16.60     71.1  ± 17.72     69.5  ± 16.82     70.7  ± 17.11  
Baseline Area of Choroidal Neovascularization (CNV) [1]
[units: mm^2]
Mean ± Standard Deviation
  6.52  ± 5.245     6.59  ± 5.052     6.49  ± 4.437     6.56  ± 5.129     6.54  ± 4.968  
Baseline Lesion Type [1]
[units: patients]
         
Occult     115     110     123     118     466  
Minimally Classic     101     105     97     112     415  
Predominantly Classic     82     87     82     71     322  
Missing     6     2     2     2     12  
Baseline Total Lesion Size [1]
[units: mm^2]
Mean ± Standard Deviation
  6.99  ± 5.491     6.98  ± 5.388     6.96  ± 4.711     6.88  ± 5.214     6.95  ± 5.202  
Baseline Best Corrected Visual Acuity (BCVA) [3]
[units: letters read]
Mean ± Standard Deviation
  54.0  ± 13.43     55.2  ± 13.15     55.5  ± 13.12     55.7  ± 12.84     55.1  ± 13.14  
[1] SAF population used for analysis.
[2] SAF population used for analysis. The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.
[3] SAF population used for analysis. BCVA assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) chart. For BCVA tested via the 4 meter ETDRS protocol, 83 letters or more would represent 20/20 vision or better which would be considered an excellent outcome. Although, the ETDRS charts include 100 letters as the maximum possible score. The worst outcome is 0 letters read.



  Outcome Measures
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1.  Primary:   Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)   [ Time Frame: Baseline and at week 52 ]

2.  Secondary:   Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - LOCF   [ Time Frame: Baseline and at week 52 ]

3.  Secondary:   Percentage of Patients Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF.   [ Time Frame: Baseline and at week 52 ]

4.  Secondary:   Mean Change From Baseline in National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF   [ Time Frame: Baseline and at Week 52 ]

5.  Secondary:   Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 (LOCF)   [ Time Frame: Baseline and at 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
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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: Clinical Trials Administrator
Organization: Regeneron Pharmaceuticals
e-mail: clinicaltrials@regeneron.com


No publications provided


Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00509795     History of Changes
Other Study ID Numbers: VGFT-OD-0605
Study First Received: July 31, 2007
Results First Received: December 16, 2011
Last Updated: December 20, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada