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Long-Term Non-Interventional Study (NIS) To Investigate The Safety And Effectiveness Of MACUGEN In Patients With Neovascular Age-Related Macular Degeneration Under Conditions Of Routine Clinical Practice

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00787319
First received: November 6, 2008
Last updated: July 20, 2012
Last verified: July 2012
History of Changes

November 6, 2008
July 20, 2012
January 2010
June 2012   (final data collection date for primary outcome measure)
  • Efficacy of Macugen [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • Which procedures are used for diagnosis of the neovascular age-related macular degeneration (AMD)? [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • What procedures are used for monitoring the course of treatment? [ Time Frame: duration of study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00787319 on ClinicalTrials.gov Archive Site
  • Compliance with Macugen treatment. [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
  • Safety profile of Macugen in routine clinical practice. [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
  • Final Physician assessment of treatment with Macugen for effectiveness and tolerability evaluated on point scale. [ Time Frame: duration of study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Long-Term Non-Interventional Study (NIS) To Investigate The Safety And Effectiveness Of MACUGEN In Patients With Neovascular Age-Related Macular Degeneration Under Conditions Of Routine Clinical Practice
Long-Term Non-Interventional Study (NIS) To Investigate The Safety And Effectiveness Of MACUGEN In Patients With Neovascular Age-Related Macular Degeneration Under Conditions Of Routine Clinical Practice

To define what procedures were used for the diagnosis and monitoring of the treatment age-related macular degeneration (AMD). What is the effect of the Macugen, compliance with Macugen treatment, safety profile of Macugen, final physician assessment of treatment with Macugen.

no sampling
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

outpatients
Age-related Macular Degeneration
Other: no intervention
Outpatients with age-related macular degeneration (AMD)
Other Name: observation only
AMD
Intervention: Other: no intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age over 18 years old
  • patients with neovascular age-related macular degeneration
  • enrollment to study is fully on physician decision in compliance with current SPC

Exclusion Criteria:

  • Patient who did not meet indication according to SPC Macugen.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT00787319
A5751032
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP