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

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.

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Key information

Conditions

Macular Degeneration Eye Diseases Retinal Degeneration Retinal Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Patients not administered Macugen®.

Treatment and study plan

pegaptanib sodium

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 )".

Other names: Macugen

Primary outcomes

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

Time frame: 2 years
The incidence of adverse drug reactions in this surveillance.

Time frame: 2 years
Adverse drug reaction not expected from the LPD (unknown adverse drug reaction).

Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Special Investigation For Long-term Use Of Macugen (Regulatory Post Marketing Commitment Plan).

Important dates

Study start: 2008
Primary completion: 2014
Study completion: 2014
First posted: Feb 18, 2009
Registry last updated: Oct 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed