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Efficacy And Safety Of Macugen In Patients With Neovascular AMD In Routine Clinical Practice.

Last updated on November 17, 2019

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Study Location
Pfizer Investigational Site
Patras, Pellopoese, Greece
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neovascular Age-related Macular Degeneration
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-90 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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adults with neovascular age-related macula degeneration

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

according to SmPC

NCT00858208
Pfizer
Completed
Efficacy And Safety Of Macugen In Patients With Neovascular AMD In Routine Clinical Practice.

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Descriptive Information
Brief TitleEfficacy And Safety Of Macugen In Patients With Neovascular AMD In Routine Clinical Practice.
Official TitleLong-Term Non-Interventional Study To Investigate The Efficacy And Safety Of MACUGEN In Patients With Neovascular Age-Related Macular Degeneration Under Conditions Of Routine Clinical Practice.
Brief SummaryEfficacy and safety of MACUGEN in patients suffering from neovascular age-related macular degeneration in routine clinical practice at least as good as demonstrated in randomized multicenter clinical trials.
Detailed DescriptionEligible patients in routine clinical practice
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationPatients with Age-related Macula degeneration
ConditionNeovascular Age-related Macular Degeneration
InterventionDrug: pegaptanib sodium
pegaptanib sodium intravitreal injection every 6 weeks for 2 years
Study Groups/CohortsPatients with neovascular Age-Related Macula Degeneration
Intervention: Drug: pegaptanib sodium
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: May 12, 2011)
86
Original Estimated Enrollment
 (submitted: March 6, 2009)
100
Actual Study Completion DateApril 2011
Actual Primary Completion DateApril 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

adults with neovascular age-related macula degeneration

Exclusion Criteria:

according to SmPC

Sex/Gender
Sexes Eligible for Study:All
Ages18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesGreece
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00858208
Other Study ID NumbersA5751028
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 DateSeptember 2011

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]

Call Now