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Trial record 1 of 1 for:    NCT00787319
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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

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ClinicalTrials.gov Identifier: NCT00787319
Recruitment Status : Completed
First Posted : November 7, 2008
Results First Posted : August 13, 2013
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date November 6, 2008
First Posted Date November 7, 2008
Results First Submitted Date May 15, 2013
Results First Posted Date August 13, 2013
Last Update Posted Date December 6, 2018
Study Start Date January 2010
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 15, 2013)
Change From Baseline in Visual Acuity (VA) at Final Visit [ Time Frame: Baseline, Final Visit (Week 104 or early termination [ET]) ]
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.
Original Primary Outcome Measures
 (submitted: November 6, 2008)
  • Which procedures are used for diagnosis of the neovascular AMD? [ Time Frame: duration of study ]
  • What procedures are used for monitoring the course of treatment? [ Time Frame: duration of study ]
  • Efficacy of Macugen [ Time Frame: duration of study ]
Change History
Current Secondary Outcome Measures
 (submitted: October 8, 2013)
  • 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 ]
    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 ]
    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) ]
    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.
Original Secondary Outcome Measures
 (submitted: November 6, 2008)
  • Compliance with Macugen treatment. [ Time Frame: duration of study ]
  • Safety profile of Macugen in routine clinical practice. [ Time Frame: duration of study ]
  • Final Physician assessment of treatment with Macugen for effectiveness and tolerability evaluated on point scale. [ Time Frame: duration of study ]
Current Other Pre-specified Outcome Measures
 (submitted: May 15, 2013)
  • 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 ]
    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) ]
    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) ]
    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) ]
  • Physician's Assessment of Tolerability [ Time Frame: Baseline up to Week 104 (EOS) ]
    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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief 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
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
Brief Summary 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.
Detailed Description no sampling
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population outpatients
Condition Age-related Macular Degeneration
Intervention Other: no intervention
Outpatients with age-related macular degeneration (AMD)
Other Name: observation only
Study Groups/Cohorts AMD
Intervention: Other: no intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 20, 2012)
108
Original Estimated Enrollment
 (submitted: November 6, 2008)
120
Actual Study Completion Date June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Czechia
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number NCT00787319
Other Study ID Numbers A5751032
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2018