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

Overview

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.

Full Title of Study: “The Efficacy, Safety, and Tolerability of Pegaptanib Sodium in Filipino Patients With Neovascular Age-related Macular Degeneration: A Post Marketing Surveillance Study.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2009

Detailed Description

Open-label, non-comparative, non-interventional study

Interventions

  • Drug: Macugen
    • Intravitreous injection of Pegaptanib Sodium 3.47 mg/mL solution every 6 weeks

Arms, Groups and Cohorts

  • Phase IV Post Marketing Surveillance Study
    • Open-label, observational study

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of adverse events and serious adverse events
    • Time Frame: 12 months

Secondary Measures

  • Mean change in visual acuity in the study eye at 6 months from baseline
    • Time Frame: 6 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Director, Clinical Trial Disclosure Group, Pfizer, Inc.
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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