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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.
All the patients whom an investigator prescribes the first MacugenĀ® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegaptanib sodium | Patients administered Pegaptanib sodium. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegaptanib sodium | Drug | 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 )". |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The patients whom an investigator involving A5751033 prescribes the MacugenĀ®).
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C495058 | pegaptanib |
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