Clinical Study Of EYE001 For Wet-Type AMD (Age-Related Macular Degeneration)


Last updated date
Study Location
Pfizer Investigational Site
Nagoya, Aichi, 466-8560, Japan


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Eligibility Criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Macular Degeneration
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Wet AMD, Visual Acuity from 20/320 to 20/40

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Diabetic retinopathy, laser coagulation history


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Advanced Information
Descriptive Information
Brief Title  ICMJE Clinical Study Of EYE001 For Wet-Type AMD (Age-Related Macular Degeneration)
Official Title  ICMJE Clinical Study Of EYE001 In Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration
Brief Summary This study will examine the efficacy and safety of pegaptanib sodium in Japanese patients with wet-type AMD, in order to establish that there is no large difference in the efficacy and the safety of the drug between Western and Japanese patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Macular Degeneration
Intervention  ICMJE Drug: pegaptanib sodium
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 6, 2005)
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Wet AMD, Visual Acuity from 20/320 to 20/40

Exclusion Criteria:

  • Diabetic retinopathy, laser coagulation history
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00150202
Other Study ID Numbers  ICMJE A5751010
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer Call CenterPfizer
PRS Account Pfizer
Verification Date November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP