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

Primary Purpose

Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
pegaptanib sodium
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring Long-Term Study For Pegaptanib Sodium In Patients With Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration

Eligibility Criteria

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

Inclusion Criteria: After completion of the preceding study (A5751010) Exclusion Criteria: Serious heart, kidney and/or liver disease Diabetic retinopathy

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EYE001

Arm Description

Outcomes

Primary Outcome Measures

Summary of Adverse Events
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

Secondary Outcome Measures

Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point
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.
Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point
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.
Number of Responders
Responders defined as subjects having lost from baseline of A5751010 (NCT00150202) less than 15 letters of visual acuity; includes subjects with visual acuity gain.
Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202)
Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity.
Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202)
Maintaining vision includes gaining 0 letter or more in visual acuity using Early Treatment Diabetic Retinopathy Study chart from baseline.
Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202)
Subjects with severe vision loss: loss from baseline of >= 30 letters of visual acuity.

Full Information

First Posted
October 13, 2005
Last Updated
May 11, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00239928
Brief Title
Clinical Study Of Pegaptanib Sodium (EYE001) For Wet-Type Age-Related Macular Degeneration
Official Title
Long-Term Study For Pegaptanib Sodium In Patients With Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration (Extension Study From A5751010)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
Long-Term Study For Pegaptanib Sodium In Patients With Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EYE001
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
pegaptanib sodium
Intervention Description
1 drop per dosed eye per protocol.
Primary Outcome Measure Information:
Title
Summary of Adverse Events
Description
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
Time Frame
Week 54 (initiation of A5751015 study) up to Week 198
Secondary Outcome Measure Information:
Title
Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point
Description
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.
Time Frame
Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Title
Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point
Description
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.
Time Frame
Weeks 54, every 18 weeks from Week 54 up to Week 198
Title
Number of Responders
Description
Responders defined as subjects having lost from baseline of A5751010 (NCT00150202) less than 15 letters of visual acuity; includes subjects with visual acuity gain.
Time Frame
Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Title
Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202)
Description
Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity.
Time Frame
Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Title
Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202)
Description
Maintaining vision includes gaining 0 letter or more in visual acuity using Early Treatment Diabetic Retinopathy Study chart from baseline.
Time Frame
Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Title
Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202)
Description
Subjects with severe vision loss: loss from baseline of >= 30 letters of visual acuity.
Time Frame
Week 0 (baseline), every 18 weeks from Week 54 up to Week 198

10. Eligibility

Sex
All
Minimum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: After completion of the preceding study (A5751010) Exclusion Criteria: Serious heart, kidney and/or liver disease Diabetic retinopathy
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
Country
Japan
Facility Name
Pfizer Investigational Site
City
Urayasu
State/Province
Chiba
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukuoka-shi
State/Province
Fukuoka-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Maebashi
State/Province
Gunma
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Pfizer Investigational Site
City
Moriguchi
State/Province
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Suita
State/Province
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Otsu
State/Province
Shiga
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chiyoda-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukushima
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kyoto
Country
Japan

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5751015&StudyName=Clinical%20Study%20Of%20EYE001%20For%20Wet-Type%20Age-Related%20Macular%20Degeneration
Description
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Clinical Study Of Pegaptanib Sodium (EYE001) For Wet-Type Age-Related Macular Degeneration

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