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

May 4, 2007 updated by: Pfizer

Clinical Study Of EYE001 In Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukushima, Japan, 960-1295
        • Pfizer Investigational Site
      • Kyoto, Japan, 606-8507
        • Pfizer Investigational Site
    • Aichi
      • Nagoya, Aichi, Japan, 466-8560
        • Pfizer Investigational Site
    • Chiba-ken
      • Urayasu-shi, Chiba-ken, Japan, 279-0021
        • Pfizer Investigational Site
    • Chiyoda-ku
      • Tokyo, Chiyoda-ku, Japan
        • Pfizer Investigational Site
    • Fukuoka-ken
      • Fukuoka-shi, Fukuoka-ken, Japan, 812-8582
        • Pfizer Investigational Site
    • Gunma
      • Maebashi, Gunma, Japan, 371-8511
        • Pfizer Investigational Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8604
        • Pfizer Investigational Site
    • Kagawa
      • Kida-gun, Kagawa, Japan, 761-0793
        • Pfizer Investigational Site
    • Osaka
      • Moriguchi, Osaka, Japan, 570-8506
        • Pfizer Investigational Site
      • Suita, Osaka, Japan, 565-0871
        • Pfizer Investigational Site
    • Shiga
      • Otsu, Shiga, Japan, 520-2192
        • Pfizer Investigational Site
    • Tokyo
      • Mitaka, Tokyo, Japan, 181-8611
        • Pfizer Investigational Site
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Diabetic retinopathy, laser coagulation history

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

May 7, 2007

Last Update Submitted That Met QC Criteria

May 4, 2007

Last Verified

November 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5751010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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