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: October 8, 2013
Last verified: October 2013
  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
Age-related Macular Degeneration
Other: no intervention

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:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline in Visual Acuity (VA) at Final Visit [ Time Frame: Baseline, Final Visit (Week 104 or early termination [ET]) ] [ Designated as safety issue: No ]
    Visual acuity (VA) measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. Decimal VA data presented as Logarithm of Minimum Angle of Resolution (logMAR), logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss, while negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts (85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results were based on study eye for which medication was given.


Secondary Outcome Measures:
  • Change From Baseline in Visual Acuity (VA) at Each Visit [ Time Frame: Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102 ] [ Designated as safety issue: No ]
    VA measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. Decimal VA data presented as logMAR, logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss, while negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts (85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results were based on study eye for which medication was given.

  • Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination [ Time Frame: Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102 ] [ Designated as safety issue: No ]
    VA measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss,negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts(85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results based on study eye for which medication was given. Number of participants with VA improved, unchanged or worsened as compared to previous examination reported.

  • Physician's Assessment of Efficacy [ Time Frame: Week 104 or End of study (EOS) ] [ Designated as safety issue: No ]
    Efficacy was based on the study eye for which pegaptanib treatment was given. Number of participants with each grade of efficacy of treatment, as assessed by the physician was reported on the 5 point categorical scale: excellent, very good, good, fair, poor.


Other Outcome Measures:
  • Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring [ Time Frame: Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102 ] [ Designated as safety issue: Yes ]
    Procedures used for diagnosis of AMD and monitoring of the course of treatment included fluorescein angiography (FA), optical coherent tomography (OCT), or other (Ot) procedure apart from FA and OCT. OCT, FA, and other are not mutually exclusive, hence same participant may be included in more than 1 procedure for AMD diagnosis and monitoring at a particular time point.

  • Number of Participants Who Discontinued Treatment Due to Adverse Events (AEs) [ Time Frame: Baseline up to Week 104 (EOS) ] [ Designated as safety issue: Yes ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

  • Duration of Treatment [ Time Frame: Baseline up to Week 104 (EOS) ] [ Designated as safety issue: Yes ]
    Duration of treatment (in weeks) was calculated as: (date of the last injection of study medication minus date of the first injection of study medication plus 1) divided by 7.

  • Mean Number of Doses of Study Medication Received [ Time Frame: Baseline up to Week 104 (EOS) ] [ Designated as safety issue: Yes ]
  • Physician's Assessment of Tolerability [ Time Frame: Baseline up to Week 104 (EOS) ] [ Designated as safety issue: No ]
    Number of participants with each grade of tolerability of treatment as assessed by physician was evaluated on the five point categorical scale: excellent, very good, good, fair, poor.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00787319     History of Changes
Other Study ID Numbers: A5751032
Study First Received: November 6, 2008
Results First Received: May 15, 2013
Last Updated: October 8, 2013
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 August 28, 2014