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

Primary Purpose

Macular Degeneration

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
pegaptanib sodium
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Wet AMD, Visual Acuity from 20/320 to 20/40 Exclusion Criteria: Diabetic retinopathy, laser coagulation history

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

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.

Full Information

First Posted
September 6, 2005
Last Updated
May 4, 2007
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00150202
Brief Title
Clinical Study Of EYE001 For Wet-Type AMD (Age-Related Macular Degeneration)
Official Title
Clinical Study Of EYE001 In Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
90 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
pegaptanib sodium
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Wet AMD, Visual Acuity from 20/320 to 20/40 Exclusion Criteria: Diabetic retinopathy, laser coagulation history
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Pfizer Investigational Site
City
Urayasu-shi
State/Province
Chiba-ken
ZIP/Postal Code
279-0021
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tokyo
State/Province
Chiyoda-ku
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukuoka-shi
State/Province
Fukuoka-ken
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Pfizer Investigational Site
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8604
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kida-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Pfizer Investigational Site
City
Moriguchi
State/Province
Osaka
ZIP/Postal Code
570-8506
Country
Japan
Facility Name
Pfizer Investigational Site
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Pfizer Investigational Site
City
Otsu
State/Province
Shiga
ZIP/Postal Code
520-2192
Country
Japan
Facility Name
Pfizer Investigational Site
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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