Long-Term Use Of Pegaptanib In Patients For Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration

NCT ID: NCT00845273

Last Updated: 2015-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3538 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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All the patients whom an investigator prescribes the first Macugen® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Conditions

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Macular Degeneration

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Pegaptanib sodium

Patients administered Pegaptanib sodium.

Pegaptanib sodium

Intervention Type DRUG

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 )".

Interventions

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Pegaptanib sodium

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 )".

Intervention Type DRUG

Other Intervention Names

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Macugen

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients not administered Macugen®.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Other Identifiers

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A5751033

Identifier Type: -

Identifier Source: org_study_id

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