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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00820742

Purpose

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	Intervention	Phase
Neovascular Age-Related Macular Degeneration	Drug: Macugen	Phase IV

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Pegaptanib sodium

U.S. FDA Resources

Study Type:	Observational
Study Design:	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.

Further study details as provided by Pfizer:

Primary Outcome Measures:

Incidence of adverse events and serious adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Mean change in visual acuity in the study eye at 6 months from baseline [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	February 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

Detailed Description:

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

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820742

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5751025
Study First Received:	January 8, 2009
Last Updated:	April 6, 2009
ClinicalTrials.gov Identifier:	NCT00820742 History of Changes
Health Authority:	Philippines: Bureau of Food and Drugs

Keywords provided by Pfizer:

A5751025

Study placed in the following topic categories:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases

Additional relevant MeSH terms:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on May 06, 2009