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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
History of Changes
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
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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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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 ]
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2.  Secondary:   Number of Participants With Change in VA: Improvement   [ Time Frame: Months 3, 6, 9 and 12 ]
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3.  Secondary:   Number of Participants With Change in VA: Stabilization   [ Time Frame: Months 3, 6, 9 and 12 ]
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4.  Secondary:   Number of Participants With Change in VA: Worsening   [ Time Frame: Months 3, 6, 9 and 12 ]
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5.  Secondary:   Duration of Treatment   [ Time Frame: Baseline up to 28.4 months ]
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6.  Secondary:   Frequency of Macugen Administration   [ Time Frame: Baseline up to 28.4 months ]
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7.  Secondary:   Number of Participants Who Received Other Concomitant Age Related Macular Degeneration (AMD) Treatments   [ Time Frame: Months 3, 6, 9 and 12 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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