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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

Last updated on November 10, 2019

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Study Location
Pfizer Investigational Site
Brno, , 625 00 Czechia
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Age-related Macular Degeneration
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patient who did not meet indication according to SPC Macugen.

NCT00787319
Pfizer
Completed
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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Descriptive Information
Brief TitleLong-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 TitleLong-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 SummaryTo 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 Descriptionno sampling
Study TypeObservational
Study DesignObservational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study Populationoutpatients
ConditionAge-related Macular Degeneration
InterventionOther: no intervention
Outpatients with age-related macular degeneration (AMD)
Other Name: observation only
Study Groups/CohortsAMD
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 StatusCompleted
Actual Enrollment
 (submitted: July 20, 2012)
108
Original Estimated Enrollment
 (submitted: November 6, 2008)
120
Actual Study Completion DateJune 2012
Actual Primary Completion DateJune 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
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesCzechia
Removed Location CountriesCzech Republic
 
Administrative Information
NCT NumberNCT00787319
Other Study ID NumbersA5751032
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2018

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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