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Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions
This study has been completed.
Study NCT00324116   Information provided by Pfizer
First Received: May 8, 2006   Last Updated: November 10, 2009   History of Changes
Study Type: Interventional
Study Design: Non-Randomized, Open Label, Single Group Assignment
Condition: Macular Degeneration
Intervention: Drug: pegaptanib sodium (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
Pegaptanib Sodium All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.

Participant Flow:   Overall Study
  Pegaptanib Sodium
STARTED   81[1]
COMPLETED   49  
NOT COMPLETED   32  
      Adverse Event               5  
      Lack of Efficacy               17  
      Withdrawal by Subject               5  
      unknown               5  
[1] subjects received treatment



  Baseline Characteristics
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Reporting Groups
  Description
Pegaptanib Sodium All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.

Baseline Measures
  Pegaptanib Sodium
Number of Participants  
[units: participants]
81
Age  
[units: years]
Mean ± Standard Deviation
76.3 ± 6.7
Gender  
[units: participants]
 
Female 47
Male 34



  Outcome Measures
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1.  Primary:   Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS)   [ Baseline, 54 Weeks ]

2.  Secondary:   Change From Baseline in Visual Acuity   [ Baseline, 6 weeks, 12 weeks, 54 weeks ]

3.  Secondary:   Number of Subjects Gaining Vision   [ 54 weeks or at early termination ]

4.  Secondary:   Number of Subjects Maintaining Vision   [ 54 weeks or at early termination ]

5.  Secondary:   Number of Subjects With Severe Visual Loss   [ 54 weeks or at early termination ]

6.  Secondary:   Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200)   [ 54 weeks ]

7.  Secondary:   Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25).   [ Baseline, 54 weeks or at early termination ]


  Serious Adverse Events
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  Other Adverse Events
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