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Study Results
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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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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 ]

Measure Type Primary
Measure Title Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS)
Measure Description Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Responders defined as subjects having lost from baseline less than 15 letters of the best-corrected visual acuity; includes subjects with visual acuity gain.
Time Frame Baseline, 54 Weeks  
Safety Issue No  

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.
The full analysis set (FAS) was derived from the set of all enrolled subjects who 1) were administered the study medication AND 2) had post-baseline documentation of efficacy available. In the case of missing data post-baseline, the subject was considered censored at the time of the last available data for the score.

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

Measured Values
  Pegaptanib Sodium
Number of Participants Analyzed
[units: participants] 		80
Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS)
[units: participants]
 		 
Responders 40
Non-Responders 7
Censored (subjects with missing data) 33


Statistical Analysis 1 for Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS)
Groups [1] Pegaptanib Sodium
percent responders [2] 85
95% Confidence Interval ( 76 to 95 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  Proportion of responders estimated by Kaplan-Meier analysis. Proportion of responders along with 95% CI calculated directly from estimate of survival distribution function. Percentage denominator = total number of subjects without missing data.



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

Measure Type Secondary
Measure Title Change From Baseline in Visual Acuity
Measure Description Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Change: mean score at observation minus mean score at baseline.
Time Frame Baseline, 6 weeks, 12 weeks, 54 weeks  
Safety Issue No  

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.
FAS; n=number of subjects with evaluable data.

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

Measured Values
  Pegaptanib Sodium
Number of Participants Analyzed
[units: participants] 		80
Change From Baseline in Visual Acuity
[units: score on scale]
Mean ± Standard Deviation 		 
6 weeks (n=76) -4.29 ± 11.11
12 weeks (n=74) -5.86 ± 13.79
54 weeks (n=49) -11.12 ± 17.96


Statistical Analysis 1 for Change From Baseline in Visual Acuity
Groups [1] Pegaptanib Sodium
Mean Difference (Net) [2] -4.29
95% Confidence Interval ( -6.83 to -1.75 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  6 weeks
[2] Other relevant estimation information:
  95% CI for the change in mean value obtained from one sample t-test.

Statistical Analysis 2 for Change From Baseline in Visual Acuity
Groups [1] Pegaptanib Sodium
Mean Difference (Net) [2] -5.86
95% Confidence Interval ( -9.06 to -2.67 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  12 weeks
[2] Other relevant estimation information:
  95% CI for the change in mean value obtained from one sample t-test.

Statistical Analysis 3 for Change From Baseline in Visual Acuity
Groups [1] Pegaptanib Sodium
Mean Difference (Net) [2] -11.12
95% Confidence Interval ( -16.28 to -5.96 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  54 weeks
[2] Other relevant estimation information:
  95% CI for the change in mean value obtained from one sample t-test.



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

Measure Type Secondary
Measure Title Number of Subjects Gaining Vision
Measure Description Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.
Time Frame 54 weeks or at early termination  
Safety Issue No  

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.
FAS

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

Measured Values
  Pegaptanib Sodium
Number of Participants Analyzed
[units: participants] 		80
Number of Subjects Gaining Vision
[units: participant]
 		 
Gained 4
Did not gain 74
Assessment Not Done 2


Statistical Analysis 1 for Number of Subjects Gaining Vision
Groups [1] Pegaptanib Sodium
percentage of subjects [2] 5.00
95% Confidence Interval ( 1.61 to 11.32 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  Proportion of subjects gaining vision was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations



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

Measure Type Secondary
Measure Title Number of Subjects Maintaining Vision
Measure Description Subjects maintaining vision: gain from baseline of more than 0 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.
Time Frame 54 weeks or at early termination  
Safety Issue No  

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.
FAS

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

Measured Values
  Pegaptanib Sodium
Number of Participants Analyzed
[units: participants] 		80
Number of Subjects Maintaining Vision
[units: participants]
 		 
Maintained 18
Did not maintain 60
Not Done 2


Statistical Analysis 1 for Number of Subjects Maintaining Vision
Groups [1] Pegaptanib Sodium
percentage of subjects [2] 22.50
95% Confidence Interval ( 14.22 to 32.11 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  Proportion of subjects maintaining vision was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations.



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

Measure Type Secondary
Measure Title Number of Subjects With Severe Visual Loss
Measure Description Subjects with severe visual loss: loss from baseline of >= 30 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.
Time Frame 54 weeks or at early termination  
Safety Issue No  

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.
FAS

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

Measured Values
  Pegaptanib Sodium
Number of Participants Analyzed
[units: participants] 		80
Number of Subjects With Severe Visual Loss
[units: participants]
 		 
Severe Loss 11
Not severe loss 67
Not Done 2


Statistical Analysis 1 for Number of Subjects With Severe Visual Loss
Groups [1] Pegaptanib Sodium
percentage of subjects [2] 13.75
95% Confidence Interval ( 7.39 to 22.24 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  Proportion of subjects with severe visual loss was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations.



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

Measure Type Secondary
Measure Title Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200)
Measure Description

Subjects with improving scores are those with > 20/200 at Baseline and progressing to =< 20/200 at Week 54.

Subjects with no change are those with > 20/200 at Baseline and remaining at > 20/200 at Week 54.
Time Frame 54 weeks  
Safety Issue No  

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.
FAS; n=77 (number of Subjects at Baseline with >20/200 Visual Acuity)

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

Measured Values
  Pegaptanib Sodium
Number of Participants Analyzed
[units: participants] 		80
Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200)
[units: participants]
 		 
Improved 20
No Change 57


Statistical Analysis 1 for Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200)
Groups [1] Pegaptanib Sodium
percentage of subjects [2] 25.97
95% Confidence Interval ( 16.28 to 34.81 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  Proportion of subjects progressing to <=20/200 was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations.



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 ]

Measure Type Secondary
Measure Title Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25).
Measure Description Patient reported vision-related functioning and quality of life as measured using the 25 item NEI-VFQ 25. Change = Mean score at 54 weeks - mean score at baseline. A positive change represents an increase in function/health from Baseline. Items grouped as the following - Composite: mean score items 1-25; General Health: item 1; General Vision: item 2; Ocular Pain:4,19; Near Vision:5,6,7; Distance Vision:8,9,14; Social Functioning:11,13; Mental Health Activities:3,21,22,25; Role Difficulties:17,18; Dependency:20,23,24; Driving:15c,16, 16a; Color Vision: 12; Peripheral Vision: 10.
Time Frame Baseline, 54 weeks or at early termination  
Safety Issue No  

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.
FAS; n=number of subjects with evaluable data.

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

Measured Values
  Pegaptanib Sodium
Number of Participants Analyzed
[units: participants] 		80
Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25).
[units: score on scale]
Mean ± Standard Deviation 		 
Composite (n=25) -2.25 ± 15.71
General Health (n=42) -4.17 ± 14.52
General Vision (n=41) 3.90 ± 16.26
Ocular Pain (n=43) 0.35 ± 15.29
Near Vision Activities (n=43) -3.88 ± 27.60
Distance Vision Activities (n=43) -6.78 ± 23.68
Social Functioning (n=43) -0.58 ± 24.84
Mental Health Activities (n=43) -0.30 ± 20.45
Role Difficulties (n=41) -4.39 ± 26.46
Dependency (n=41) -5.28 ± 22.15
Driving (n=27) -3.70 ± 30.67
Color Vision (n=41) -1.83 ± 18.87
Peripheral Vision (n=42) -4.17 ± 25.25

No statistical analysis provided for Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25).




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


No publications provided


Responsible Party: Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers: A5751016
Study First Received: May 8, 2006
Results First Received: August 25, 2009
Last Updated: November 10, 2009
ClinicalTrials.gov Identifier: NCT00324116     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency





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