Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    NCT00150202
Previous Study | Return to List | Next Study

Clinical Study Of EYE001 For Wet-Type AMD (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: NCT00150202
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : May 7, 2007
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 6, 2005
First Posted Date  ICMJE September 8, 2005
Last Update Posted Date May 7, 2007
Study Start Date  ICMJE July 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2005)
Visual aquity change from the baseline to 54 weeks after the first treatment is expected to be similar to that seen in the Western studies.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00150202 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2005)
Safety profile of pegaptanib including side effects and lab test from the baseline to 54 weeks after the first treatment. Blood concentration of the drug from the baseline to 54 weeks after the irst treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 6, 2005)
90
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 CT.gov Call Center Pfizer
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