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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. Identifier: NCT00150202
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : May 7, 2007
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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.

Condition or disease Intervention/treatment Phase
Macular Degeneration Drug: pegaptanib sodium Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Clinical Study Of EYE001 In Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration
Study Start Date : July 2004
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Diabetic retinopathy, laser coagulation history

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00150202

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

Layout table for additonal information Identifier: NCT00150202     History of Changes
Other Study ID Numbers: A5751010
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: May 7, 2007
Last Verified: November 2006
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases