A Multi-Center Trial To Evaluate The Safety And Efficacy Of Pegaptanib Sodium(Macugen) Injected Into The Eye Every 6 Weeks For Up To 2 Years For Macular Swelling Associated With Diabetes, With An Open-Label Macugen Year Extension.

October 18, 2018 updated by: Pfizer

A Phase 2/3 Randomized, Controlled, Double-Masked, Multi-Center, Comparative Trial, In Parallel Groups, To Compare The Safety And Efficacy Of Intravitreous Injections Of 0.3 Mg Pegaptanib Sodium (Macugen®), Given As Often As Every 6 Weeks For 2 Years, To Sham Injections In Subjects With Diabetic Macular Edema (DME) Involving The Center Of The Macula With An Open-Label Macugen Year 3 Extension.

The purpose of the study is to test whether Macugen injected into the eye improves vision in more patients than the currently existing standard of care laser therapy. The safety of Macugen compared to standard of care laser will also be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

317

Phase

  • Phase 2
  • Phase 3

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

  • Australia
      • East Melbourne, Australia
        • Pfizer Investigational Site
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Pfizer Investigational Site
  • Austria
      • Innsbruck, Austria, A-6020
        • Pfizer Investigational Site
      • Wien, Austria, A-1180
        • Pfizer Investigational Site
  • Brazil
      • Porto Alegre, Brazil, 90035-003
        • Pfizer Investigational Site
      • Sao Paolo, Brazil, SP 04524-20
        • Pfizer Investigational Site
      • Sao Paulo, Brazil, 04524-020
        • Pfizer Investigational Site
    • GO
      • Gioania, GO, Brazil, 74210-010
        • Pfizer Investigational Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 3N9
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H1T 2H1
        • Pfizer Investigational Site
  • Colombia
      • Bogota, Colombia
        • Pfizer Investigational Site
  • Czechia
      • Brno, Czechia, 625 00
        • Pfizer Investigational Site
      • Hradec Kralove, Czechia, 50005
        • Pfizer Investigational Site
      • Olomouc, Czechia, 775 20
        • Pfizer Investigational Site
      • Praha 4, Czechia, 140 00
        • Pfizer Investigational Site
      • Praha 6, Czechia, 169 00
        • Pfizer Investigational Site
  • Denmark
      • Glostrup, Denmark, 2600
        • Pfizer Investigational Site
  • France
      • Clermont, France, 63003
        • Pfizer Investigational Site
      • Lyon, France, 69006
        • Pfizer Investigational Site
      • Marseille, France, 13008
        • Pfizer Investigational Site
      • Marseille Cedex 5, France, 13385
        • Pfizer Investigational Site
      • Marsielle, France, 13008
        • Pfizer Investigational Site
      • Nancy Cedex, France, 54035
        • Pfizer Investigational Site
      • Paris Cedex 12, France, 75571
        • Pfizer Investigational Site
    • Cedex
      • Creteil, Cedex, France, 94010
        • Pfizer Investigational Site
  • Germany
      • Bonn, Germany, 53105
        • Pfizer Investigational Site
      • Duesseldorf, Germany, 40225
        • Pfizer Investigational Site
      • Heidelberg, Germany, 69120
        • Pfizer Investigational Site
      • Leipzig, Germany, 04103
        • Pfizer Investigational Site
      • Muenster, Germany, 48145
        • Pfizer Investigational Site
      • Tuebingen, Germany, 72706
        • Pfizer Investigational Site
  • Greece
      • Athens, Greece, 12462
        • Pfizer Investigational Site
  • India
      • Ahmedabad, India, 380 004
        • Pfizer Investigational Site
      • Bangalore, India, 560 085
        • Pfizer Investigational Site
      • Hyderabad, India, 500 034
        • Pfizer Investigational Site
      • New Delhi, India, 110 029
        • Pfizer Investigational Site
  • Italy
      • Firenze, Italy, 50134
        • Pfizer Investigational Site
      • Milano, Italy, 20132
        • Pfizer Investigational Site
      • Udine, Italy, 33100
        • Pfizer Investigational Site
  • Netherlands
      • Nijmegen, Netherlands, 6500
        • Pfizer Investigational Site
  • Portugal
      • Coimbra, Portugal, 3000-354
        • Pfizer Investigational Site
  • South Africa
      • Bloemfontein, South Africa, 9301
        • Pfizer Investigational Site
  • Switzerland
      • Bern, Switzerland, CH-3010
        • Pfizer Investigational Site
  • United Kingdom
      • Newcastle Upon Tyne, United Kingdom, NE1 4LP
        • Pfizer Investigational Site
      • Sheffield, United Kingdom, S10 2JF
        • Pfizer Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Pfizer Investigational Site
      • Tucson, Arizona, United States, 85704
        • Pfizer Investigational Site
    • California
      • Los Angeles, California, United States, 90095
        • Pfizer Investigational Site
      • Oakland, California, United States, 94609
        • Pfizer Investigational Site
      • Santa Ana, California, United States, 92705
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80230
        • Pfizer Investigational Site
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Pfizer Investigational Site
    • Florida
      • Fort Lauderdale, Florida, United States, 33334-4146
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33609
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33612
        • Pfizer Investigational Site
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Pfizer Investigational Site
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46280
        • Pfizer Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Pfizer Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48201-1423
        • Pfizer Investigational Site
    • New York
      • Lynbrook, New York, United States, 11563
        • Pfizer Investigational Site
      • New York, New York, United States, 10021
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Pfizer Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Pfizer Investigational Site
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
        • Pfizer Investigational Site
    • Texas
      • Abilene, Texas, United States, 79606
        • Pfizer Investigational Site
      • Fort Worth, Texas, United States, 76104
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77002
        • Pfizer Investigational Site
      • McAllen, Texas, United States, 78503
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78240
        • Pfizer Investigational Site
      • Temple, Texas, United States, 76508
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • 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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • macular edema associated with diabetes
  • visual acuity between 20/50 and 20/200

Exclusion Criteria:

  • recent laser therapy in the eye
  • recent signs of uncontrolled diabetes
  • blood pressure worse than 160/100
  • severe cardiac disease

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Sham Control
Drug: Standard of Care
Clinicians decision to use optional laser therapy.
EXPERIMENTAL: Macugen
Drug: Macugen
Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks up to 2 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year
Time Frame: Baseline, Year 1
Refraction and best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts
Baseline, Year 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With a ≥ 10 Letter (or 2 Line) Improvement in Vision at 2 Years
Time Frame: Baseline, Year 2
Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts
Baseline, Year 2
Number of Participants With a ≥ 15 Letter Improvement in Vision at 1 Year
Time Frame: Baseline, Year 1
Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts
Baseline, Year 1
Number of Participants With a ≥ 15 Letter Improvement in Vision at 2 Years
Time Frame: Baseline, Year 2
Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts
Baseline, Year 2
Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 1 Year
Time Frame: Baseline, Year 1
Retinopathy changes were monitored using fundus photography and fluorescein angiograph (FA) assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where an increase in the step or retinopathy level indicated a worsening of the condition.
Baseline, Year 1
Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 1 Year
Time Frame: Baseline, Year 1
Retinopathy changes were monitored using fundus photography and FA assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where a decrease in the step or retinopathy level indicated an improvement.
Baseline, Year 1
Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 2 Years
Time Frame: Baseline, Year 2
Retinopathy changes were monitored using fundus photography and FA assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where an increase in the step or retinopathy level indicated a worsening of the condition.
Baseline, Year 2
Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 2 Years
Time Frame: Baseline, Year 2
Retinopathy changes were monitored using fundus photography and FA assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where a decrease in the step or retinopathy level indicated an improvement.
Baseline, Year 2
Change From Baseline in Mean VA Score at 1 Year
Time Frame: Baseline, Year 1
Changes in VA monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS chart with participants at a 4-meter distance from chart. Distance VA expressed as an ETDRS score (number of letters correctly read) ranging from 0 to 60, where higher ETDRS scores represented better vision. Change from baseline for each patient equaled the visual acuity obtained at the observation minus the visual acuity at baseline.
Baseline, Year 1
Change From Baseline in Mean VA Score at 2 Years
Time Frame: Baseline, Year 2
Changes in VA monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS chart with participants at a 4-meter distance from chart. Distance VA expressed as an ETDRS score (number of letters correctly read) ranging from 0 to 60, where higher ETDRS scores represented better vision. Change from baseline for each patient equaled the visual acuity obtained at the observation minus the visual acuity at baseline.
Baseline, Year 2
Number of Participants Requiring Focal or Grid Laser Treatment During Year 1
Time Frame: 1 year
Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation
1 year
Number of Participants Requiring Focal or Grid Laser Treatment During Year 2
Time Frame: 2 years
Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation
2 years

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.

General Publications

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, 2009

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

January 18, 2008

First Submitted That Met QC Criteria

January 30, 2008

First Posted (ESTIMATE)

January 31, 2008

Study Record Updates

Last Update Posted (ACTUAL)

November 16, 2018

Last Update Submitted That Met QC Criteria

October 18, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5751013
  • EOP1013H

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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