Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Macugen Observational Study

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00735943
First received: August 14, 2008
Last updated: August 26, 2011
Last verified: August 2011
Results First Received: July 21, 2011  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Conditions: Vascular Endothelial Growth Factor
Macular Degeneration
Intervention: Other: No intervention

  Participant Flow
  Hide Participant Flow

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 Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.

Participant Flow:   Overall Study
    Pegaptanib  
STARTED     22  
COMPLETED     20  
NOT COMPLETED     2  
Lost to Follow-up                 1  
Adverse Event                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Pegaptanib Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.

Baseline Measures
    Pegaptanib  
Number of Participants  
[units: participants]
  22  
Age  
[units: years]
Mean ± Standard Deviation
  70.4  ± 10.9  
Gender  
[units: participants]
 
Female     8  
Male     14  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Showing Stabilization, Improvement or Deterioration of Visual Acuity (VA)   [ Time Frame: Baseline through 12 months or last follow-up visit before study termination ]

2.  Primary:   Average Number of Injections to Achieve Stabilization of VA   [ Time Frame: 12 months or last follow-up visit before study termination ]

3.  Primary:   Median Number of Injections to Achieve Stabilization of VA   [ Time Frame: 12 months or last follow-up visit before study termination ]

4.  Secondary:   Percentage of Participants Receiving Macugen Monotherapy Versus Those Receiving a Combination Therapy   [ Time Frame: 12 months or last follow-up visit before study termination ]

5.  Secondary:   Percentage of Participants Showing Improvement in Optical Coherence Tomography (OCT) Parameters   [ Time Frame: 12 months or last follow-up visit before study termination ]

6.  Secondary:   Percentage of Participants Showing Improvement in Fundus Fluorescein Angiography (FFA) Parameters   [ Time Frame: 12 months or last follow-up visit before study termination ]

7.  Secondary:   Percentage of Participants With Early Lesions Showing Stabilization and Improvement of VA   [ Time Frame: 12 months or last follow-up visit before study termination ]

8.  Secondary:   Average Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions   [ Time Frame: 12 months or last follow-up visit before study termination ]

9.  Secondary:   Median Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions   [ Time Frame: 12 months or last follow-up visit before study termination ]

10.  Secondary:   Percentage of Participants With Occult or Minimally Classic and Classic Lesions Showing Stabilization and Improvement in VA   [ Time Frame: 12 months or last follow-up visit before study termination ]

11.  Secondary:   Percentage of Participants Who Were Treatment Naive When Started on Macugen Versus Those Previously Treated by Any Other Therapy Except Macugen   [ Time Frame: 12 months or last follow-up visit before study termination ]

12.  Secondary:   Percentage of Participants Showing Stabilization or Improvement in VA in the Subgroup Previously Treated by Other Therapy   [ Time Frame: 12 months or last follow-up visit before study termination ]

13.  Secondary:   Percentage of Participants Showing Improvement in OCT in the Subgroup Previously Treated by Other Therapy   [ Time Frame: 12 months or last follow-up visit before study termination ]

14.  Secondary:   Percentage of Participants Showing Improvement in OCT in the Subgroup Which Were Not Treatment Naive   [ Time Frame: 12 months or last follow-up visit before study termination ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
Outcome measures were not designated as primary or secondary measures as this study was an observational non-interventional study.


  More Information
  Hide More Information

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: NCT00735943     History of Changes
Other Study ID Numbers: A5751031
Study First Received: August 14, 2008
Results First Received: July 21, 2011
Last Updated: August 26, 2011
Health Authority: India: Institutional Review Board