Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO) (GALILEO)

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01012973
First received: October 30, 2009
Last updated: January 30, 2014
Last verified: January 2014
Results First Received: October 23, 2012  
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
Condition: Retinal Vein Occlusion
Interventions: Biological: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Other: Sham treatment

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Aflibercept Injection First, Then Aflibercept Injection Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
Sham Treatment First, Then Aflibercept Injection Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.

Participant Flow:   Overall Study
    Aflibercept Injection First, Then Aflibercept Injection     Sham Treatment First, Then Aflibercept Injection  
STARTED     106     71  
Participants Received Treatment     104 [1]   68 [1]
Fulfilled Requirements of FAS Population     103 [2]   68 [2]
Completed Week 24, From FAS     97     57  
Completed Week 52, From FAS     91     52  
COMPLETED     90     52  
NOT COMPLETED     16     19  
Adverse Event                 5                 5  
Lack of Efficacy                 0                 5  
Lost to Follow-up                 1                 0  
(Overseas travel - indefinite period)                 1                 0  
Increase in vis. acuity, never injected                 0                 1  
Protocol Violation                 5                 2  
Withdrawal by Subject                 4                 6  
[1] Safety Population: Participants received treatment
[2] Full Analysis Set (FAS) Population: Participants received treatment with post baseline measurements



  Baseline Characteristics
  Hide 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.
No text entered.

Reporting Groups
  Description
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321) Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
Sham Treatment Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
Total Total of all reporting groups

Baseline Measures
    Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)     Sham Treatment     Total  
Number of Participants  
[units: participants]
  104     68     172  
Age  
[units: Years]
Mean ± Standard Deviation
  60.0  ± 12.3     63.8  ± 13.3     61.5  ± 12.8  
Gender  
[units: Participants]
     
Female     45     31     76  
Male     59     37     96  
Ethnicity (NIH/OMB)  
[units: Participants]
     
Hispanic or Latino     4     1     5  
Not Hispanic or Latino     100     66     166  
Unknown or Not Reported     0     1     1  
Baseline Best Corrected Visual Acuity (BCVA) letter scores [1]
[units: Letters correctly read]
Mean ± Standard Deviation
  53.5  ± 15.7     50.9  ± 15.4     52.5  ± 15.6  
Number of participants with baseline retinal perfusion [2]
[units: Participants]
     
Perfused     90     54     144  
Nonperfused     7     7     14  
Indeterminate     7     7     14  
Baseline Retinal Thickness by Optical Coherence Tomography (OCT)  
[units: microns]
Mean ± Standard Deviation
  682.78  ± 233.36     638.66  ± 224.69     665.34  ± 230.33  
Baseline intraocular pressure  
[units: mm Hg]
Mean ± Standard Deviation
  15.2  ± 2.8     14.4  ± 2.7     14.9  ± 2.8  
Number of participants with time since Central retinal vein occlusion (CRVO) diagnosis  
[units: Participants]
     
>= 2 months     46     33     79  
< 2 months     56     35     91  
Missing     2     0     2  
Baseline National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) total score [3]
[units: scores on a scale]
Mean ± Standard Deviation
  79.66  ± 13.06     78.94  ± 14.00     79.38  ± 13.40  
European questionnaire 5 dimensions (EQ-5D) total score [4]
[units: score on a scale]
Mean ± Standard Deviation
  0.87  ± 0.15     0.86  ± 0.16     0.87  ± 0.15  
Race  
[units: Participants]
     
Asian     26     15     41  
White     75     49     124  
Unknown or Not Reported     3     4     7  
[1] Infiormation 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.
[2] Retinal perfusion defined as less than 10 disc areas of capillary nonperfusion using fluorescein angiography (FA)
[3] 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.
[4] The EQ-5D total score ranges from -0.594 to 1.000 with -0.594 being the worst.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 24 With Discontinued Participants Before Week 24 Evaluated as Failures   [ Time Frame: Baseline and Week 24 ]

2.  Secondary:   Change From Baseline in BCVA as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 24 - Last Observation Carried Forward (LOCF)   [ Time Frame: Baseline and Week 24 ]

3.  Secondary:   Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF   [ Time Frame: Baseline and Week 24 ]

4.  Secondary:   Percentage of Participants Who Developed Neovascularization During the First 24 Weeks   [ Time Frame: From baseline until Week 24 ]

5.  Secondary:   Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 24 - LOCF   [ Time Frame: Baseline and Week 24 ]

6.  Secondary:   Change From Baseline in European Five-dimensional Health Scale (EQ-5D) Score at Week 24 - LOCF   [ Time Frame: Baseline and Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide 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: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


Publications of Results:

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01012973     History of Changes
Other Study ID Numbers: 14130, 2009-010973-19
Study First Received: October 30, 2009
Results First Received: October 23, 2012
Last Updated: January 30, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Latvia: State Agency of Medicines
Japan: Pharmaceuticals and Medical Devices Agency
Singapore: Health Sciences Authority
South Korea: Korea Food and Drug Administration (KFDA)