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A Study On The Efficacy Of Macugen Injections In Patients With Neovascular Age-Related Macular Degeneration In Real Life. (MACURELI)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00549055
First received: October 23, 2007
Last updated: February 15, 2011
Last verified: February 2011
Results First Received: October 1, 2010  
Study Type: Observational
Study Design: Observational Model: Cohort
Condition: Exudative Age-related Macular Degeneration
Intervention: Drug: Macugen

  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
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Reporting Groups
  Description
Macugen Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.

Participant Flow:   Overall Study
    Macugen  
STARTED     38  
COMPLETED     3  
NOT COMPLETED     35  
Adverse Event                 4  
Lack of efficacy                 18  
Stabilization                 5  
Progression to fibrosis                 2  
Decrease of size                 1  
Active choroidal neovascula increased                 1  
Vitreous hemorrhage                 1  
Growth choroidal neovascularisation                 1  
Choroidal neovascularization                 1  
Very low visual acuity (VA)                 1  



  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
Macugen Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.

Baseline Measures
    Macugen  
Number of Participants  
[units: participants]
  38  
Age, Customized  
[units: Participants]
 
< 65 years     3  
65 to 74 years     8  
75 to 84 years     22  
>= 85 years     5  
Gender  
[units: Participants]
 
Female     14  
Male     24  



  Outcome Measures
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1.  Primary:   Change From Baseline to Final Visit in Visual Acuity (VA) Score   [ Time Frame: Baseline, Month 24 or Early Termination ]

2.  Secondary:   Number of Participants With Change in VA: Improvement   [ Time Frame: Months 3, 6, 9 and 12 ]

3.  Secondary:   Number of Participants With Change in VA: Stabilization   [ Time Frame: Months 3, 6, 9 and 12 ]

4.  Secondary:   Number of Participants With Change in VA: Worsening   [ Time Frame: Months 3, 6, 9 and 12 ]

5.  Secondary:   Duration of Treatment   [ Time Frame: Baseline up to 28.4 months ]

6.  Secondary:   Frequency of Macugen Administration   [ Time Frame: Baseline up to 28.4 months ]

7.  Secondary:   Number of Participants Who Received Other Concomitant Age Related Macular Degeneration (AMD) Treatments   [ Time Frame: Months 3, 6, 9 and 12 ]


  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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00549055     History of Changes
Other Study ID Numbers: A5751026
Study First Received: October 23, 2007
Results First Received: October 1, 2010
Last Updated: February 15, 2011
Health Authority: Belgium: Institutional Review Board