Efficacy, Safety, Tolerability of Pegaptanib Sodium (Macu... | NCT00820742

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

NCT00820742

Sponsor

Pfizer

Status

Withdrawn

Last Update Posted

Mar 5, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Neovascular Age-related Macular Degeneration

Interventions

Macugen

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

May 2009Estimated

Completion Date

May 2009Estimated

First Submitted Date

Jan 8, 2009

First Submission Date that Met QC Criteria

Jan 9, 2009

First Posted Date

Jan 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2015

Last Update Posted Date

Mar 5, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Phase IV Post Marketing Surveillance Study		Open-label, observational study	Drug: Macugen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Macugen	Drug	Intravitreous injection of Pegaptanib Sodium 3.47 mg/mL solution every 6 weeks	Phase IV Post Marketing Surveillance Study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of adverse events and serious adverse events		12 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Not provided

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

References Module

Citations

Not provided