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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00150202
First received: September 6, 2005
Last updated: May 4, 2007
Last verified: November 2006
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Clinical Study Of EYE001 In Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 90
Study Start Date: July 2004
Study Completion Date: October 2006
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Diabetic retinopathy, laser coagulation history
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150202

Locations
Japan
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00150202     History of Changes
Other Study ID Numbers: A5751010
Study First Received: September 6, 2005
Last Updated: May 4, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Macular Degeneration
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014