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

May 11, 2011 updated by: Pfizer

Long-Term Study For Pegaptanib Sodium In Patients With Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration (Extension Study From A5751010)

This study will examine the safety and efficacy of pegaptanib sodium in Japanese patients with wet-type age-related macular degeneration (AMD), who benefit further treatment and who want to continue the treatment after completion of the preceding study (A5751010).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukushima, Japan
        • Pfizer Investigational Site
      • Kyoto, Japan
        • Pfizer Investigational Site
    • Aichi
      • Nagoya, Aichi, Japan
        • Pfizer Investigational Site
    • Chiba
      • Urayasu, Chiba, Japan
        • Pfizer Investigational Site
    • Fukuoka-ken
      • Fukuoka-shi, Fukuoka-ken, Japan
        • Pfizer Investigational Site
    • Gunma
      • Maebashi, Gunma, Japan
        • Pfizer Investigational Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Pfizer Investigational Site
    • Osaka
      • Moriguchi, Osaka, Japan
        • Pfizer Investigational Site
      • Suita, Osaka, Japan
        • Pfizer Investigational Site
    • Shiga
      • Otsu, Shiga, Japan
        • Pfizer Investigational Site
    • Tokyo
      • Chiyoda-ku, Tokyo, Japan
        • Pfizer Investigational Site
      • Shinjuku-ku, Tokyo, Japan
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

47 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • After completion of the preceding study (A5751010)

Exclusion Criteria:

  • Serious heart, kidney and/or liver disease
  • Diabetic retinopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EYE001
Drug: pegaptanib sodium
1 drop per dosed eye per protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Summary of Adverse Events
Time Frame: Week 54 (initiation of A5751015 study) up to Week 198
Number of subjects with serious and non-serious adverse events: Subjects with ophthalmic adverse events: Subjects with severe adverse events that interferes significantly with subject's usual function: Subjects discontinued due to adverse events: Subjects with dose reduction or temporary discontinuation due to adverse events
Week 54 (initiation of A5751015 study) up to Week 198

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point
Time Frame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198

Change: value at each observation time point minus value at baseline of A5751010 (NCT00150202).

Visual acuity was measured as number of letters that the participants for this study could read in Early Treatment Diabetic Retinopathy Study (ETDRS) chart (eyesight-test chart).The best value in visual acuity using ETDRS chart is 85 and the worst value in visual acuity is 0.
Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point
Time Frame: Weeks 54, every 18 weeks from Week 54 up to Week 198

Value at each observation time point minus value at Week 54 (initiation of current study).

Visual acuity was measured as number of letters that the participants for this study could read in Early Treatment Diabetic Retinopathy Study (ETDRS) chart (eyesight-test chart).The best value in visual acuity using ETDRS chart is 85 and the worst value in visual acuity is 0.
Weeks 54, every 18 weeks from Week 54 up to Week 198
Number of Responders
Time Frame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Responders defined as subjects having lost from baseline of A5751010 (NCT00150202) less than 15 letters of visual acuity; includes subjects with visual acuity gain.
Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202)
Time Frame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity.
Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202)
Time Frame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Maintaining vision includes gaining 0 letter or more in visual acuity using Early Treatment Diabetic Retinopathy Study chart from baseline.
Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202)
Time Frame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Subjects with severe vision loss: loss from baseline of >= 30 letters of visual acuity.
Week 0 (baseline), every 18 weeks from Week 54 up to Week 198

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

October 13, 2005

First Submitted That Met QC Criteria

October 13, 2005

First Posted (Estimate)

October 17, 2005

Study Record Updates

Last Update Posted (Estimate)

May 12, 2011

Last Update Submitted That Met QC Criteria

May 11, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5751015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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