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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Special Investigation For Long-Term Use Of Macugen (Regulatory Post Marketing Commitment Plan)|
- Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- The incidence of adverse drug reactions in this surveillance. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Patients administered Pegaptanib sodium.
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 )".
Other Name: Macugen
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.