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Trial record 2 of 6 for:    CATT

Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00593450
First received: January 3, 2008
Last updated: October 10, 2016
Last verified: October 2016
Results First Received: June 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Age Related Macular Degeneration
Interventions: Drug: ranibizumab
Drug: bevacizumab

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Note: The Data and Safety Monitoring Committee for CATT recommended excluding the data for all patients (N=23) from one center because of serious protocol non-compliance. Unless specified otherwise, only the 1185 patients enrolled by the remaining 43 centers are included in analyses.

Reporting Groups
  Description
1-Lucentis Monthly Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
2-Avastin Monthly Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
3-Lucentis as Needed Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
4-Avastin as Needed Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.

Participant Flow:   Overall Study
    1-Lucentis Monthly   2-Avastin Monthly   3-Lucentis as Needed   4-Avastin as Needed
STARTED   301   286   298   300 
COMPLETED   284   265   285   271 
NOT COMPLETED   17   21   13   29 



  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
1-Lucentis Monthly Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
2-Avastin Monthly Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
3-Lucentis as Needed Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
4-Avastin as Needed Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
Total Total of all reporting groups

Baseline Measures
   1-Lucentis Monthly   2-Avastin Monthly   3-Lucentis as Needed   4-Avastin as Needed   Total 
Overall Participants Analyzed 
[Units: Participants]
 301   286   298   300   1185 
Age 
[Units: Years]
Mean (Standard Deviation)
 79.2  (7.4)   80.1  (7.3)   78.4  (7.8)   79.3  (7.6)   79.3  (7.5) 
Age, Customized 
[Units: Participants]
         
50-59 years   2   1   6   2   11 
60-69 years   33   28   31   34   126 
70-79 years   102   84   115   103   404 
80-89 years   142   150   126   142   560 
>=90 years   22   23   20   19   84 
Gender 
[Units: Participants]
         
Female   183   180   185   184   732 
Male   118   106   113   116   453 
Race/Ethnicity, Customized 
[Units: Participants]
         
White   297   281   296   294   1168 
Other   4   5   2   6   17 
History of myocardial infarction 
[Units: Participants]
         
Yes   34   40   30   36   140 
No   267   246   268   264   1045 
History of stroke 
[Units: Participants]
         
Yes   14   18   22   16   70 
No   287   268   276   284   1115 
History of transient ischemic attack 
[Units: Participants]
         
Yes   12   25   12   19   68 
No   289   261   286   281   1117 
Systolic blood pressure 
[Units: Mm Hg]
Mean (Standard Deviation)
 134  (18)   135  (19)   136  (17)   135  (17)   135  (18) 
Diastolic blood pressure 
[Units: Mm Hg]
Mean (Standard Deviation)
 75  (10)   75  (10)   76  (9)   75  (10)   75  (10) 
Visual-acuity score and Snellen equivalent 
[Units: Participants]
         
68-82 letters, 20/25-40   111   94   116   103   424 
53-67 letters, 20/50-80   98   118   108   119   443 
38-52 letters, 20/100-160   67   53   58   58   236 
23-37 letters, 20/200-320   25   21   16   20   82 
Visual-acuity score and Snellen equivalent [1] 
[Units: Letters]
Mean (Standard Deviation)
 60.1  (14.3)   60.2  (13.1)   61.5  (13.2)   60.4  (13.4)   60.5  (13.5) 
[1]

Visual acuity testing was performed with the Electronic Visual Tester (EVA) following the ETDRS protocol. VA score is measured as number of letters read correctly.

In this study, the visual acuity letter score is ranged from 23 to 82, with the higher score the better visual acuity.

Total thickness at fovea 
[Units: μm]
Mean (Standard Deviation)
 458  (184)   463  (196)   458  (193)   461  (175)   460  (187) 
Retinal thickness plus subfoveal-fluid thickness at fovea 
[Units: Microns]
Mean (Standard Deviation)
 251  (122)   254  (121)   247  (122)   252  (115)   251  (120) 
Foveal center involvement 
[Units: Participants]
         
Choroidal neovacularization   176   153   176   183   688 
Fluid   85   81   77   72   315 
Hemorrhage   20   24   24   25   93 
Other   18   20   15   18   71 
No choroidal neovascularization or can't grade   2   8   6   2   18 


  Outcome Measures
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1.  Primary:   Change From Baseline in Visual-acuity Score (Continuous)   [ Time Frame: Baseline and 1 Year ]

2.  Secondary:   Change From Baseline Visual-acuity Score (Frequency)   [ Time Frame: Baseline and 1 Year ]

3.  Secondary:   Visual-acuity Score and Snellen Equivalent (Frequency)   [ Time Frame: at 1 Year ]

4.  Secondary:   Visual-acuity Score and Snellen Equivalent (Continuous)   [ Time Frame: at 1 Year ]

5.  Secondary:   Number of Treatments   [ Time Frame: 1 Year ]

6.  Secondary:   Average Cost of Drug/Patient   [ Time Frame: at 1 Year ]

7.  Secondary:   Total Thickness at Fovea   [ Time Frame: at 1 Year ]

8.  Secondary:   Total Thickness Change From Baseline at Fovea   [ Time Frame: Baseline and 1 Year ]

9.  Secondary:   Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea   [ Time Frame: at 1 Year ]

10.  Secondary:   Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea   [ Time Frame: Baseline and 1 Year ]

11.  Secondary:   Fluid on Optical Coherence Tomography   [ Time Frame: at 1 Year ]

12.  Secondary:   Dye Leakage on Angiogram   [ Time Frame: at 1 Year ]

13.  Secondary:   Area of Lesion   [ Time Frame: at 1 Year ]

14.  Secondary:   Area of Lesion Change From Baseline   [ Time Frame: Baseline and 1 Year ]

15.  Secondary:   Change in Systolic Blood Pressure From Baseline   [ Time Frame: Baseline and 1 Year ]

16.  Secondary:   Change in Diastolic Blood Pressure From Baseline   [ Time Frame: Baseline and 1 Year ]


  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: Dr. Maureen Maguire
Organization: CATT Research Group
phone: 215-615-1501
e-mail: maguirem@mail.med.upenn.edu


Publications of Results:
Martin DF, Maguire MG, Fine SL. Ranibizumab and bevacizumab for AMD. Authors reply. N Engl J Med 2011; 365:2237

Other Publications:

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00593450     History of Changes
Other Study ID Numbers: NEI-137
U10EY017823 ( US NIH Grant/Contract Award Number )
Study First Received: January 3, 2008
Results First Received: June 18, 2012
Last Updated: October 10, 2016
Health Authority: United States: Food and Drug Administration