The study will provide additional safety data for specific safety events in persons receiving intravitreal injections. The Committee for Medicinal Products for Human Use (CHMP) is interested in obtaining additional safety information when Macugen is used in real world settings by practitioners in Europe treating patients with neovascular (wet) age-related macular degeneration (AMD). The study will provide information about physician practice patterns and characteristics of patients treated with Macugen.
- Neovascular AMD patients who are eligible for Macugen therapy based on the approved
label
- Active or suspected ocular or periocular infection. Known hypersensitivity to the
active substance or any of its excipients.
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Ocular Safety Of Patients Receiving Macugen For Neovascular Age Related Macular Degeneration | |||
| Official Title | European Epidemiologic COHORT Study: A Prospective Epidemiologic COHORT Study Of Ocular Safety In Patients Receiving Macugen Injections For Neovascular Age-Related Macular Degeneration (AMD) In Europe | |||
| Brief Summary | The study will provide additional safety data for specific safety events in persons receiving intravitreal injections. The Committee for Medicinal Products for Human Use (CHMP) is interested in obtaining additional safety information when Macugen is used in real world settings by practitioners in Europe treating patients with neovascular (wet) age-related macular degeneration (AMD). The study will provide information about physician practice patterns and characteristics of patients treated with Macugen. | |||
| Detailed Description | No comparator Patients with age-related macular degeneration | |||
| Study Type | Observational | |||
| Study Design | Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | Patients with age-related macular degeneration | |||
| Condition | Macular Degeneration | |||
| Intervention | Drug: Macugen Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks. | |||
| Study Groups/Cohorts | Observational study, no comparator Observational study of patients with AMD treated with Macugen, no comparator Intervention: Drug: Macugen | |||
| 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 | 501 | |||
| Original Enrollment | 550 | |||
| Actual Study Completion Date | February 2012 | |||
| Actual Primary Completion Date | February 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 | Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Greece, Ireland, Italy, Poland, Slovakia, Spain, Sweden | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00460408 | |||
| Other Study ID Numbers | A5751019 | |||
| 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 2012 | |||
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
