Efficacy 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.
adults with neovascular age-related macula degeneration
according to SmPC
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Efficacy And Safety Of Macugen In Patients With Neovascular AMD In Routine Clinical Practice. | |||
| Official Title | Long-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 Summary | Efficacy 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 Description | Eligible patients in routine clinical practice | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | Patients with Age-related Macula degeneration | |||
| Condition | Neovascular Age-related Macular Degeneration | |||
| Intervention | Drug: pegaptanib sodium pegaptanib sodium intravitreal injection every 6 weeks for 2 years | |||
| Study Groups/Cohorts | Patients 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 Status | Completed | |||
| Actual Enrollment | 86 | |||
| Original Estimated Enrollment | 100 | |||
| Actual Study Completion Date | April 2011 | |||
| Actual Primary Completion Date | April 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 |
| |||
| Ages | 18 Years to 90 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Greece | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00858208 | |||
| Other Study ID Numbers | A5751028 | |||
| 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 | September 2011 | |||
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
