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

Completed

• Conditions: Macular Degeneration
• Interventions: Drug: Pegaptanib sodium

• Registration Number: NCT00845273
• Lead Sponsor: Pfizer

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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-12-09
• Study First Submitted QC: 2009-02-16
• Study First Posted: 2009-02-18
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-30
• Last Update Posted: 2015-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3538

Inclusion Criteria

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

Exclusion Criteria

• Patients not administered Macugen®.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pegaptanib sodium	Pegaptanib sodium	Patients administered Pegaptanib sodium.

Primary Outcome Measures

Name	Time	Method
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