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

Phase 3

Completed

• Conditions: Macular Degeneration

• Registration Number: NCT00150202
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Study Completion: 2006-10
• Status Verified: 2006-11
• Last Update Submitted: 2007-05-04
• Last Update Posted: 2007-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

Exclusion Criteria

• Diabetic retinopathy, laser coagulation history

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Kyoto, Japan