Efficacy, Safety, Tolerability of Pegaptanib Sodium (Macugen) in Filipino Patients With Neovascular Age Related Macular Degeneration.
NCT00820742
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- Must have at least one eye which was diagnosed with neovascular degeneration
- 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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Descriptive Information | ||||
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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Recruitment Status | Withdrawn | |||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 |