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

March 4, 2015 updated by: Pfizer

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Study Population

Male of female 50 years and older, diagnosed with age-related macular degeneration

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events and serious adverse events
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Anticipated)

May 1, 2009

Study Completion (Anticipated)

May 1, 2009

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

January 9, 2009

First Posted (Estimate)

January 12, 2009

Study Record Updates

Last Update Posted (Estimate)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5751025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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