An Open Label Trial to Investigate Macugen for the Preservation of Visual Function in Subjects With Neovascular AMD (PERSPECTIVES)

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00327470
First received: May 17, 2006
Last updated: April 2, 2012
Last verified: January 2011
Results First Received: April 13, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Age Related Macular Degeneration (AMD)
Macular Degeneration
Choroidal Neovascularization (CNV)
Intervention: Drug: Pegaptanib Sodium 0.3 mg

  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
Early Age-related Macular Degeneration (AMD) Subjects with early choroidal neovascularization (CNV) lesions were distinguished from subjects with established CNV lesions based on the stage of evolution of their CNV as determined by fluorescein angiography and, where available, indocyanine green angiography as assessed by the investigator at Baseline. Subjects with early CNV lesions were treated in the study eye with Macugen (0.3 milligram [mg]) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
Established AMD Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).

Participant Flow:   Overall Study
    Early Age-related Macular Degeneration (AMD)     Established AMD  
STARTED     107     181  
Treated     107     179  
COMPLETED     78     118  
NOT COMPLETED     29     63  
Randomized, but not treated                 0                 2  
Adverse Event                 9                 14  
Lack of Efficacy                 7                 19  
Unknown                 5                 9  
Lost to Follow-up                 1                 3  
Withdrawal by Subject                 6                 12  
Death                 1                 4  



  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
Early AMD Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
Established AMD Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
Total Total of all reporting groups

Baseline Measures
    Early AMD     Established AMD     Total  
Number of Participants  
[units: participants]
  107     179     286  
Age, Customized  
[units: Participants]
     
45 through 64 years     12     24     36  
>= 65 years     95     155     250  
Gender  
[units: Participants]
     
Female     59     108     167  
Male     48     71     119  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change From Baseline Through Week 54 in Distance Visual Acuity (VA) in Subjects With Early and Established CNV Lesions   [ Time Frame: Baseline through Week 54 ]

2.  Secondary:   Mean Change From Baseline in Distance VA in Subjects With Early and Established CNV Lesions   [ Time Frame: Baseline through Week 102, Week 54 through Week 102 ]

3.  Secondary:   Mean Change From Baseline in Near VA in Subjects With Early and Established CNV Lesions   [ Time Frame: Baseline through Week 54, Baseline through Week 102 ]

4.  Secondary:   Mean Change in Reading Speed   [ Time Frame: Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102 ]

5.  Secondary:   Mean Change From Baseline in Contrast Sensitivity   [ Time Frame: Baseline through Week 54, Baseline through Week 102 ]

6.  Secondary:   Mean Change in National Eye Institute – Visual Functioning Questionnaire (NEI-VFQ-25) Composite Score   [ Time Frame: Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102 ]

7.  Secondary:   Mean Change in Euro QoL Questionnaire (EQ-5D) Score   [ Time Frame: Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102 ]


  Serious Adverse Events


  Other Adverse Events


  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.


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.gov_Inquiries@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00327470     History of Changes
Other Study ID Numbers: A5751017
Study First Received: May 17, 2006
Results First Received: April 13, 2010
Last Updated: April 2, 2012
Health Authority: Turkey:Ministry of Health Central Ethics Committee