Ocular Safety Of Patients Receiving Macugen For Neovascular Age Related Macular Degeneration

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00460408
First received: April 13, 2007
Last updated: November 14, 2012
Last verified: November 2012
Results First Received: September 24, 2012  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: 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
No text entered.

Reporting Groups
  Description
Macugen The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
Macugen and Avastin The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
Macugen and Lucentis The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
Macugen and Other AMD Drugs The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.

Participant Flow:   Overall Study
    Macugen     Macugen and Avastin     Macugen and Lucentis     Macugen and Other AMD Drugs  
STARTED     403     16     75     7  
COMPLETED     336     13     69     7  
NOT COMPLETED     67     3     6     0  
Adverse Event                 1                 0                 0                 0  
Death                 7                 0                 0                 0  
Lost to Follow-up                 11                 0                 1                 0  
Withdrawal by Subject                 31                 0                 0                 0  
Insufficient clinical response                 5                 1                 5                 0  
Unspecified                 12                 2                 0                 0  



  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 The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
Macugen and Avastin The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
Macugen and Lucentis The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
Macugen and Other AMD Drugs The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
Total Total of all reporting groups

Baseline Measures
    Macugen     Macugen and Avastin     Macugen and Lucentis     Macugen and Other AMD Drugs     Total  
Number of Participants  
[units: participants]
  403     16     75     7     501  
Age, Customized  
[units: participants]
         
less than or equal to (≤) 50 years     5     0     0     0     5  
51 to 64 years     68     1     9     1     79  
65 to 74 years     121     7     19     2     149  
greater than or equal to (≥) 75 years     209     8     47     4     268  
Gender  
[units: participants]
         
Female     245     11     46     5     307  
Male     158     5     29     2     194  
Smoking status [1]
[units: participants]
         
Never smoked     265     12     45     5     327  
Current smoker     34     1     8     0     43  
Exsmoker     103     3     22     2     130  
[1] Data missing for 1 participant in Macugen monotherapy reporting group.



  Outcome Measures
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1.  Primary:   Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection   [ Time Frame: Baseline up to 2 years ]

2.  Primary:   Incidence of POAEs Per Injection Reported by Gender (Females)   [ Time Frame: Baseline up to 2 years ]

3.  Secondary:   Incidence of POAEs Per Injection Reported by Gender (Males)   [ Time Frame: Baseline up to 2 years ]

4.  Secondary:   Incidence of POAEs Per Injection Reported by Age Group (≤ 50 Years)   [ Time Frame: Baseline up to 2 years ]

5.  Secondary:   Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years)   [ Time Frame: Baseline up to 2 years ]

6.  Secondary:   Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years)   [ Time Frame: Baseline up to 2 years ]

7.  Secondary:   Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years)   [ Time Frame: Baseline up to 2 years ]

8.  Secondary:   Number of Participants With Serious Hypersensitivity Reactions   [ Time Frame: Baseline up to 2 years ]


  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: Pfizer
ClinicalTrials.gov Identifier: NCT00460408     History of Changes
Other Study ID Numbers: A5751019
Study First Received: April 13, 2007
Results First Received: September 24, 2012
Last Updated: November 14, 2012
Health Authority: United States: Food and Drug Administration