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Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD) (VIEW 2)

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00637377
First received: March 12, 2008
Last updated: April 25, 2014
Last verified: April 2014
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: Drug: Ranibizumab
Biological: Aflibercept Injection (EYLEA, 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 186 study centers in 26 countries. Recruitment period: 21 Apr 2008 - 4 Sep 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2031 participants were screened, 1240 were randomized and 1204 received at least 1 dose of study drug. 1204 participants were included in the Safety-Analysis Set (SAS). 1202 participants with at least 1 post-baseline measurement were included in the Full-Analysis Set (FAS).

Reporting Groups
  Description
Ranibizumab 0.5mg Q4 Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4 Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4 Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8 Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.

Participant Flow:   Overall Study
    Ranibizumab 0.5mg Q4     Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4     Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4     Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8  
STARTED     303     313     311     313  
Participants Received Treatment     291 [1]   309 [1]   297 [1]   307 [1]
Participants Treated (FAS)     291     309     296     306  
COMPLETED     276     281     274     284  
NOT COMPLETED     27     32     37     29  
Adverse Event                 2                 6                 8                 9  
Death                 1                 3                 2                 1  
Lack of Efficacy                 0                 0                 1                 1  
Lost to Follow-up                 4                 1                 2                 2  
Protocol Violation                 2                 1                 1                 0  
Withdrawal by Subject                 11                 15                 13                 11  
Other (no further information available)                 7                 6                 10                 5  
[1] safety population



  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 Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4 Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4 Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8 Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Ranibizumab 0.5mg Q4     Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4     Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4     Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8     Total  
Number of Participants  
[units: participants]
  291     309     296     306     1202  
Age  
[units: years]
Mean ± Standard Deviation
  73.0  ± 9.0     74.1  ± 8.5     74.7  ± 8.6     73.8  ± 8.6     73.9  ± 8.7  
Gender [1]
[units: participants]
         
Female     169     176     147     175     667  
Male     122     133     149     131     535  
Ethnicity [1]
[units: participants]
         
Not Hispanic or Latino     239     259     241     251     990  
Hispanic or Latino     52     50     55     55     212  
Race [1]
[units: participants]
         
White     213     226     219     217     875  
Black or African American     1     0     1     2     4  
Asian     60     67     61     69     257  
Missing     17     16     15     18     66  
National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) total score [2]
[units: scores on a scale]
Mean ± Standard Deviation
  72.90  ± 19.09     70.27  ± 19.41     74.04  ± 18.22     71.30  ± 19.06     72.10  ± 18.99  
Area of Choroidal Neovascularization (CNV) [3]
[units: mm^2]
Mean ± Standard Deviation
  7.59  ± 5.34     8.25  ± 5.77     7.70  ± 5.26     7.75  ± 5.52     7.83  ± 5.48  
Baseline lesion type [4]
[units: participants]
         
Predominantly classic     70     72     80     88     310  
Minimally classic     104     112     103     106     425  
Occult     116     123     113     110     462  
Missing     1     2     0     2     5  
Baseline total lesion size [5]
[units: mm^2]
Mean ± Standard Deviation
  8.01  ± 5.74     8.72  ± 6.14     8.17  ± 5.51     8.22  ± 5.87     8.28  ± 5.82  
Best Corrected Visual Acuity (BCVA), assessed by ETDRS chart [6]
[units: Letters correctly read]
Mean ± Standard Deviation
  53.8  ± 13.5     52.8  ± 13.9     51.6  ± 14.2     51.6  ± 13.9     52.4  ± 13.9  
[1] Information retrieved from all baseline participants.
[2] Information retrieved from 1201/1202 baseline participants. The possible range of the NEI VFQ-25 total score is between 0 (worst possible) and 100 (best possible).
[3] Information retrieved from 1200/1202 baseline participants.
[4] Information retrieved from 1197/1202 baseline participants.
[5] Information retrieved from 1198/1202 baseline participants.
[6] Information retrieved from all baseline participants. Only participants with a ETDRS (Early Treatment Diabetic Retinopathy Study) Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye at 4 meters were included; a higher score represents better functioning.



  Outcome Measures
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1.  Primary:   Percentage of Participants Who Maintained Vision at Week 52 – Last Observation Carried Forward (LOCF)   [ Time Frame: At week 52 ]

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

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

4.  Secondary:   Mean Change From Baseline in National Eye Institute 25-item Visual Function 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
The conditional sequence of hypothesis testing had to stop after testing the first superiority hypothesis. Therefore, all further statistical tests are exploratory tests.


  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


Publications of Results:

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00637377     History of Changes
Other Study ID Numbers: 91689, 2007-000583-25
Study First Received: March 12, 2008
Results First Received: December 16, 2011
Last Updated: April 25, 2014
Health Authority: Switzerland: Swiss Medic
Argentina: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: ANVISA Agencia Nacional de Vigilancia Sanitaria
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India
Israel: Ministry of Health
Italy: Ethics Committee
Japan: Pharmaceuticals and Medical Devices Agency
South Korea: Korea Food and Drug Administration (KFDA)
Latvia: State Agency of Medicines
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: INFARMED National Authority of Medicines and Health Products
Singapore: Health Sciences Authority
Slovakia: State Institute for Drug Control
Spain: Ministry of Health and Consumption
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency