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

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00820742
• Other study ID #: A5751025
• Status: Withdrawn
• Phase: Phase 4
• First received: January 8, 2009
• Last updated: March 4, 2015
• Start date: February 2008
• Est. completion date: May 2009

Study information

• Verified date: March 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Bureau of Food and Drugs
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events and serious adverse events		12 months	Yes
Secondary	Mean change in visual acuity in the study eye at 6 months from baseline		6 months	Yes

External Links

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