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.
- 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 | ||||
|---|---|---|---|---|
| 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:
| |||
| 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 | |||
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
