NCT00150202

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2004

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

May 7, 2007

Status Verified

November 1, 2006

First QC Date

September 6, 2005

Last Update Submit

May 4, 2007

Conditions

Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • 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.

Interventions

pegaptanib sodiumDRUG

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Diabetic retinopathy, laser coagulation history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Pfizer Investigational Site

Nagoya, Aichi-ken, 466-8560, Japan

Location

Pfizer Investigational Site

Urayasu-shi, Chiba, 279-0021, Japan

Location

Pfizer Investigational Site

Tokyo, Chiyoda-ku, Japan

Location

Pfizer Investigational Site

Fukuoka, Fukuoka, 812-8582, Japan

Location

Pfizer Investigational Site

Fukushima, Fukushima, 960-1295, Japan

Location

Pfizer Investigational Site

Maebashi, Gunma, 371-8511, Japan

Location

Pfizer Investigational Site

Sapporo, Hokkaido, 060-8604, Japan

Location

Pfizer Investigational Site

Kida-gun, Kagawa-ken, 761-0793, Japan

Location

Pfizer Investigational Site

Kyoto, Kyoto, 606-8507, Japan

Location

Pfizer Investigational Site

Moriguchi, Osaka, 570-8506, Japan

Location

Pfizer Investigational Site

Suita, Osaka, 565-0871, Japan

Location

Pfizer Investigational Site

Ōtsu, Shiga, 520-2192, Japan

Location

Pfizer Investigational Site

Mitaka, Tokyo, 181-8611, Japan

Location

Pfizer Investigational Site

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

pegaptanib

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

July 1, 2004

Study Completion

October 1, 2006

Last Updated

May 7, 2007

Record last verified: 2006-11

Locations

JP(14)