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Trial record 1 of 1 for:    NCT00845273
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Long-Term Use Of Pegaptanib In Patients For Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00845273
Recruitment Status : Completed
First Posted : February 18, 2009
Last Update Posted : October 2, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date December 9, 2008
First Posted Date February 18, 2009
Last Update Posted Date October 2, 2015
Study Start Date November 2008
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 16, 2009)
  • Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 2 years ]
  • The incidence of adverse drug reactions in this surveillance. [ Time Frame: 2 years ]
  • Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 2 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long-Term Use Of Pegaptanib In Patients For Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration
Official Title Special Investigation For Long-term Use Of Macugen (Regulatory Post Marketing Commitment Plan).
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The patients whom an investigator involving A5751033 prescribes the Macugen®).
Condition Macular Degeneration
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 )".

Other Name: Macugen
Study Groups/Cohorts Pegaptanib sodium
Patients administered Pegaptanib sodium.
Intervention: Drug: Pegaptanib sodium
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 3, 2015)
3538
Original Estimated Enrollment
 (submitted: February 16, 2009)
1000
Actual Study Completion Date February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients not administered Macugen®.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00845273
Other Study ID Numbers A5751033
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2015