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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 
Overall Participants Analyzed 
[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) 
[1] SAF population used for analysis.
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 
[1] SAF population used for analysis.
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 
[1] SAF population used for analysis.
Baseline National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) total score [1] 
[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) 
[1] 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.
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) 
[1] SAF population used for analysis.
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 
[1] SAF population used for analysis.
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) 
[1] SAF population used for analysis.
Baseline Best Corrected Visual Acuity (BCVA) [1] 
[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. 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


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

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