NCT00845273

Brief Summary

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
3,538

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2008

Longer than P75 for all trials

Status
completed

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

November 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 9, 2008

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

October 2, 2015

Status Verified

September 1, 2015

Enrollment Period

5.3 years

First QC Date

December 9, 2008

Last Update Submit

September 30, 2015

Conditions

Macular Degeneration

Keywords

Subfoveal choroidal neovascularization secondary to age-related macular degeneration

Outcome Measures

Primary Outcomes (3)

  • Factors considered to affect the safety and/or efficacy of this drug.

    2 years

  • The incidence of adverse drug reactions in this surveillance.

    2 years

  • Adverse drug reaction not expected from the LPD (unknown adverse drug reaction).

    2 years

Study Arms (1)

Pegaptanib sodium

Patients administered Pegaptanib sodium.

Drug: Pegaptanib sodium

Interventions

Pegaptanib sodiumDRUG

Macugen Intravitreous Injection Kit 0.3mg depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "Pegaptanib sodium is administered intravitreously once every 6 weeks at a dose level of 0.3 mg (on an oligonucleotide of pegaptanib basis )".

Also known as: Macugen
Pegaptanib sodium

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patients whom an investigator involving A5751033 prescribes the Macugen®).

You may qualify if:

  • Patients need to be administered Macugen® in order to be enrolled in the surveillance.

You may not qualify if:

  • Patients not administered Macugen®.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Macular Degeneration

Interventions

pegaptanib

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2008

First Posted

February 18, 2009

Study Start

November 1, 2008

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

October 2, 2015

Record last verified: 2015-09