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Trial record 1 of 1 for:    NCT00593450
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Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial

This study has been completed.
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Maureen Maguire, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00593450
First received: January 3, 2008
Last updated: August 21, 2012
Last verified: August 2012
History of Changes
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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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  
Number of Participants  
[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  
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  
[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.



  Outcome Measures
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1.  Primary:   Change From Baseline in Visual-acuity Score (Continuous)   [ Time Frame: Baseline and 1 Year ]
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2.  Secondary:   Change From Baseline Visual-acuity Score (Frequency)   [ Time Frame: Baseline and 1 Year ]
  Show Outcome Measure 2

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

4.  Secondary:   Visual-acuity Score and Snellen Equivalent (Continuous)   [ Time Frame: at 1 Year ]
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5.  Secondary:   Number of Treatments   [ Time Frame: 1 Year ]
  Show Outcome Measure 5

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

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

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

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

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

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

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

14.  Secondary:   Area of Lesion Change From Baseline   [ Time Frame: Baseline and 1 Year ]
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15.  Secondary:   Change in Systolic Blood Pressure From Baseline   [ Time Frame: Baseline and 1 Year ]
  Show Outcome Measure 15

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


  Serious Adverse Events
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  Other Adverse Events
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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.


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.  


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:

Other Publications:


Responsible Party: Maureen Maguire, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00593450     History of Changes
Other Study ID Numbers: NEI-137, U10EY017823
Study First Received: January 3, 2008
Results First Received: June 18, 2012
Last Updated: August 21, 2012
Health Authority: United States: Food and Drug Administration