You are here

Ocular Safety Of Patients Receiving Macugen For Neovascular Age Related Macular Degeneration

Last updated on November 13, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bruxelles, , 1200 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
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

- Neovascular AMD patients who are eligible for Macugen therapy based on the approved
label

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

- Active or suspected ocular or periocular infection. Known hypersensitivity to the
active substance or any of its excipients.

NCT00460408
Pfizer
Completed
Ocular Safety Of Patients Receiving Macugen For Neovascular Age Related Macular Degeneration

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Descriptive Information
Brief TitleOcular Safety Of Patients Receiving Macugen For Neovascular Age Related Macular Degeneration
Official TitleEuropean Epidemiologic COHORT Study: A Prospective Epidemiologic COHORT Study Of Ocular Safety In Patients Receiving Macugen Injections For Neovascular Age-Related Macular Degeneration (AMD) In Europe
Brief SummaryThe study will provide additional safety data for specific safety events in persons receiving intravitreal injections. The Committee for Medicinal Products for Human Use (CHMP) is interested in obtaining additional safety information when Macugen is used in real world settings by practitioners in Europe treating patients with neovascular (wet) age-related macular degeneration (AMD). The study will provide information about physician practice patterns and characteristics of patients treated with Macugen.
Detailed DescriptionNo comparator Patients with age-related macular degeneration
Study TypeObservational
Study DesignTime Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationPatients with age-related macular degeneration
ConditionMacular Degeneration
InterventionDrug: Macugen
Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks.
Study Groups/CohortsObservational study, no comparator
Observational study of patients with AMD treated with Macugen, no comparator
Intervention: Drug: Macugen
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 24, 2012)
501
Original Enrollment
 (submitted: April 13, 2007)
550
Actual Study Completion DateFebruary 2012
Actual Primary Completion DateFebruary 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Neovascular AMD patients who are eligible for Macugen therapy based on the approved label

Exclusion Criteria:

  • Active or suspected ocular or periocular infection. Known hypersensitivity to the active substance or any of its excipients.
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 CountriesBelgium,   Cyprus,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Ireland,   Italy,   Poland,   Slovakia,   Spain,   Sweden
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00460408
Other Study ID NumbersA5751019
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 2012

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