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
Last updated date
ABOUT THIS STUDY
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.
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.
Age-related Macular Degeneration
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ 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
- 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
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Patient who did not meet indication according to SPC Macugen.
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Advanced Information
| 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 | |||