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

Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00150202
• Other study ID #: A5751010
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2005
• Last updated: May 4, 2007
• Start date: July 2004
• Est. completion date: October 2006

Study information

• Verified date: November 2006
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Diabetic retinopathy, laser coagulation history

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Macular Degeneration

Intervention

Drug:
• pegaptanib sodium

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Fukuoka-shi	Fukuoka-ken
Japan	Pfizer Investigational Site	Fukushima
Japan	Pfizer Investigational Site	Kida-gun	Kagawa
Japan	Pfizer Investigational Site	Kyoto
Japan	Pfizer Investigational Site	Maebashi	Gunma
Japan	Pfizer Investigational Site	Mitaka	Tokyo
Japan	Pfizer Investigational Site	Moriguchi	Osaka
Japan	Pfizer Investigational Site	Nagoya	Aichi
Japan	Pfizer Investigational Site	Otsu	Shiga
Japan	Pfizer Investigational Site	Sapporo	Hokkaido
Japan	Pfizer Investigational Site	Shinjuku-ku	Tokyo
Japan	Pfizer Investigational Site	Suita	Osaka
Japan	Pfizer Investigational Site	Tokyo	Chiyoda-ku
Japan	Pfizer Investigational Site	Urayasu-shi	Chiba-ken

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.