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

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NCT00460408

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Study Location
Pfizer Investigational Site
Bruxelles, , 1200, Belgium
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

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

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1-800-718-1021

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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.

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Advanced Information
Descriptive Information
Brief Title Ocular Safety Of Patients Receiving Macugen For Neovascular Age Related Macular Degeneration
Official Title European 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 Summary The 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 Description No comparator Patients with age-related macular degeneration
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with age-related macular degeneration
Condition Macular Degeneration
Intervention Drug: Macugen
Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks.
Study Groups/Cohorts Observational 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 Status Completed
Actual Enrollment
 (submitted: July 24, 2012)		501
Original Enrollment
 (submitted: April 13, 2007)		550
Actual Study Completion Date February 2012
Actual Primary Completion Date February 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
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 Belgium,   Cyprus,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Ireland,   Italy,   Poland,   Slovakia,   Spain,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT00460408
Other Study ID Numbers A5751019
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 CenterPfizer
PRS Account Pfizer
Verification Date November 2012