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

Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00845273
• Other study ID #: A5751033
• Status: Completed
• Phase: N/A
• First received: December 9, 2008
• Last updated: September 30, 2015
• Start date: November 2008
• Est. completion date: February 2014

Study information

• Verified date: September 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3538
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients not administered Macugen®.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

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 )".

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Factors considered to affect the safety and/or efficacy of this drug.		2 years	Yes
Primary	The incidence of adverse drug reactions in this surveillance.		2 years	Yes
Primary	Adverse drug reaction not expected from the LPD (unknown adverse drug reaction).		2 years	Yes

External Links

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