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
NCT00787319
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- Patient who did not meet indication according to SPC Macugen.
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Descriptive Information | ||||
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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 | 108 | |||
Original Estimated Enrollment | 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:
Exclusion Criteria:
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Sex/Gender |
| |||
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 |
| |||
PRS Account | Pfizer | |||
Verification Date | November 2018 |