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


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Macular Degeneration


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

This study is currently recruiting patients.
Verified by Pfizer September 2005

Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00150202

Purpose

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 Intervention Phase
Macular Degeneration
 Drug: pegaptanib sodium
Phase II

MedlinePlus related topics:  Macular Degeneration

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

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

Further Study Details: 
Primary Outcomes: 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 Outcomes: 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.
Expected Total Enrollment:  90

Study start: July 2004

Eligibility

Ages Eligible for Study:  50 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Diabetic retinopathy, laser coagulation history

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00150202

Pfizer CT.gov Call Center      1-800-718-1021 

Japan
      Pfizer Investigational Site, Fukushima,  960-1295,  Japan; Recruiting

      Pfizer Investigational Site, Kyoto,  606-8507,  Japan; Recruiting

Japan, Aichi
      Pfizer Investigational Site, Nagoya,  Aichi,  466-8560,  Japan; Recruiting

Japan, CHIBA-KEN
      Pfizer Investigational Site, Urayasu-shi,  CHIBA-KEN,  279-0021,  Japan; Recruiting

Japan, Chiyoda-ku
      Pfizer Investigational Site, Tokyo,  Chiyoda-ku,  Japan; Recruiting

Japan, Fukuoka-ken
      Pfizer Investigational Site, Fukuoka-shi,  Fukuoka-ken,  812-8582,  Japan; Recruiting

Japan, Gunma
      Pfizer Investigational Site, Maebashi,  Gunma,  371-8511,  Japan; Recruiting

Japan, Hokkaido
      Pfizer Investigational Site, Sapporo,  Hokkaido,  060-8604,  Japan; Recruiting

Japan, Kagawa
      Pfizer Investigational Site, Kida-gun,  Kagawa,  761-0793,  Japan; Recruiting

Japan, Osaka
      Pfizer Investigational Site, Suita,  Osaka,  565-0871,  Japan; Recruiting

      Pfizer Investigational Site, Moriguchi,  Osaka,  570-8506,  Japan; Recruiting

Japan, Shiga
      Pfizer Investigational Site, Otsu,  Shiga,  520-2192,  Japan; Recruiting

Japan, Tokyo
      Pfizer Investigational Site, Mitaka,  Tokyo,  181-8611,  Japan; Recruiting

      Pfizer Investigational Site, Shinjuku-ku,  Tokyo,  160-8582,  Japan; Recruiting

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

More Information

Study ID Numbers:  A5751010
Last Updated:  September 7, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00150202
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13


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