Text Size

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
  Purpose

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.


Condition Intervention Phase
Age-related Macular Degeneration
 Other: no intervention
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 108
Study Start Date: January 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
AMD Other: no intervention
Outpatients with age-related macular degeneration (AMD)
Other Name: observation only

Detailed Description:

no sampling

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

outpatients

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00787319

Locations
Czech Republic
Pfizer Investigational Site
Brno, Czech Republic, 62500
Pfizer Investigational Site
Brno, Czech Republic, 625 00
Pfizer Investigational Site
Olomouc, Czech Republic, 775 20
Pfizer Investigational Site
Olomouc, Czech Republic, 77520
Pfizer Investigational Site
Ostrava - Poruba, Czech Republic, 70852
Pfizer Investigational Site
Plzen, Czech Republic, 304 60
Pfizer Investigational Site
Praha 2, Czech Republic, 128 08
Pfizer Investigational Site
Praha 2, Czech Republic, 12808
Pfizer Investigational Site
Praha 6, Czech Republic, 169 00
Pfizer Investigational Site
Praha 6, Czech Republic, 169 02
Pfizer Investigational Site
Usti nad Labem, Czech Republic, 40113
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00787319     History of Changes
Other Study ID Numbers: A5751032
Study First Received: November 6, 2008
Last Updated: July 20, 2012
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by Pfizer:
Ophthalmology
Age-related macular degeneration
outpatients

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013