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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00845273

Enrollment

3538

Registered

2009-02-18

Start date

2008-11-30

Completion date

2014-02-28

Last updated

2015-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Degeneration

Keywords

Subfoveal choroidal neovascularization secondary to age-related macular degeneration

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.

Interventions

DRUGPegaptanib 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 ).

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Patients not administered Macugen®.

Design outcomes

Primary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026