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Efficacy, Safety, Tolerability of Pegaptanib Sodium (Macugen) in Filipino Patients With Neovascular Age Related Macular Degeneration.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00820742
Recruitment Status : Withdrawn
First Posted : January 12, 2009
Last Update Posted : March 5, 2015
Sponsor:
Information provided by:
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment
Neovascular Age-related Macular Degeneration Drug: Macugen

Detailed Description:
Open-label, non-comparative, non-interventional study
Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Time Perspective: Prospective
Official Title: The Efficacy, Safety, and Tolerability of Pegaptanib Sodium in Filipino Patients With Neovascular Age-related Macular Degeneration: A Post Marketing Surveillance Study.
Study Start Date : February 2008
Estimated Primary Completion Date : May 2009
Estimated Study Completion Date : May 2009

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Phase IV Post Marketing Surveillance Study
Open-label, observational study
 Drug: Macugen
Intravitreous injection of Pegaptanib Sodium 3.47 mg/mL solution every 6 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events and serious adverse events [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Mean change in visual acuity in the study eye at 6 months from baseline [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Study Population
Male of female 50 years and older, diagnosed with age-related macular degeneration
Criteria

Inclusion Criteria:

  • Must have at least one eye which was diagnosed with neovascular degeneration

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820742


Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00820742    
Other Study ID Numbers: A5751025
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: March 2015
Keywords provided by Pfizer:
A5751025
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases