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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00845273
First received: December 9, 2008
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Macular Degeneration
 Drug: Pegaptanib sodium
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Investigation For Long-Term Use Of Macugen (Regulatory Post Marketing Commitment Plan)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1000
Study Start Date: November 2008
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pegaptanib sodium
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The patients whom an investigator involving A5751033 prescribes the Macugen®).

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients not administered Macugen®.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845273

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00845273     History of Changes
Other Study ID Numbers: A5751033
Study First Received: December 9, 2008
Last Updated: May 1, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:
Subfoveal choroidal neovascularization secondary to age-related macular degeneration

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
 Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on May 21, 2013