NCT00845273

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,538 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Macular Degeneration

Interventions

Type	Name	Description
DRUG	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 )".

Timeline

• Start date: 2008-11-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2009-02-18
• Last updated: 2015-10-02