NCT00820742

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2008

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

March 5, 2015

Status Verified

March 1, 2015

Enrollment Period

1.2 years

First QC Date

January 8, 2009

Last Update Submit

March 4, 2015

Conditions

Neovascular Age-related Macular Degeneration

Keywords

A5751025

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events and serious adverse events

    12 months

Secondary Outcomes (1)

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

    6 months

Study Arms (1)

Phase IV Post Marketing Surveillance Study

Open-label, observational study

Drug: Macugen

Interventions

MacugenDRUG

Intravitreous injection of Pegaptanib Sodium 3.47 mg/mL solution every 6 weeks

Phase IV Post Marketing Surveillance Study

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Interventions

pegaptanib

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 8, 2009

First Posted

January 12, 2009

Study Start

February 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

March 5, 2015

Record last verified: 2015-03