Efficacy And Safety Of Macugen In Patients With Neovascular AMD In Routine Clinical Practice.
NCT00858208
Last updated date
ABOUT THIS STUDY
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.
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
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neovascular Age-related Macular Degeneration
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-90 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
adults with neovascular age-related macula degeneration
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
according to SmPC
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Advanced Information
| 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 | |||