Efficacy, Safety, Tolerability of Pegaptanib Sodium (Macugen) in Filipino Patients With Neovascular Age Related Macular Degeneration.
NCT00820742
Last updated date
ABOUT THIS STUDY
An open label, non-comparative, multicenter, non-interventional, post marketing surveillance
study to evaluate the overall safety and tolerability of pegaptanib sodium(Macugen) in the
treatment of Filipino patients with neovascular age-related macular degeneration based on
incidence of adverse events and to evaluate the efficacy based on visual acuity, and the
patient's and physician's overall satisfaction with tolerability and efficacy.
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
50 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Must have at least one eye which was diagnosed with neovascular degeneration
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Presence of other causes of choroidal neovascularization, including pathologic myopia
(spherical equivalent of -8 diopters or more negative, or axial length of 25mm or
more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, multifocal
choroiditis
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Efficacy, Safety, Tolerability of Pegaptanib Sodium (Macugen) in Filipino Patients With Neovascular Age Related Macular Degeneration. | |||
| Official Title | The Efficacy, Safety, and Tolerability of Pegaptanib Sodium in Filipino Patients With Neovascular Age-related Macular Degeneration: A Post Marketing Surveillance Study. | |||
| Brief Summary | An open label, non-comparative, multicenter, non-interventional, post marketing surveillance study to evaluate the overall safety and tolerability of pegaptanib sodium(Macugen) in the treatment of Filipino patients with neovascular age-related macular degeneration based on incidence of adverse events and to evaluate the efficacy based on visual acuity, and the patient's and physician's overall satisfaction with tolerability and efficacy. | |||
| Detailed Description | Open-label, non-comparative, non-interventional study | |||
| Study Type | Observational | |||
| Study Design | Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Not Provided | |||
| Study Population | Male of female 50 years and older, diagnosed with age-related macular degeneration | |||
| Condition | Neovascular Age-related Macular Degeneration | |||
| Intervention | Drug: Macugen
Intravitreous injection of Pegaptanib Sodium 3.47 mg/mL solution every 6 weeks | |||
| Study Groups/Cohorts | Phase IV Post Marketing Surveillance Study
Open-label, observational study 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 | Withdrawn | |||
| Actual Enrollment | 0 | |||
| Original Estimated Enrollment | 100 | |||
| Estimated Study Completion Date | May 2009 | |||
| Estimated Primary Completion Date | May 2009 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | 50 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 | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00820742 | |||
| Other Study ID Numbers | A5751025 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | March 2015 | |||