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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.

Primary Purpose

Macular Edema Associated With Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Standard of Care
Macugen
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Edema Associated With Diabetes Mellitus focused on measuring randomized sham-controlled multicenter macular edema

Eligibility Criteria

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

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

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
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  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • 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
  • 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
  • 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
  • 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 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham Control

Macugen

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants With a ≥ 10 Letter (or 2 Line) Improvement in Vision at 2 Years
Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts
Number of Participants With a ≥ 15 Letter Improvement in Vision at 1 Year
Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts
Number of Participants With a ≥ 15 Letter Improvement in Vision at 2 Years
Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts
Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 1 Year
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.
Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 1 Year
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.
Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 2 Years
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.
Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 2 Years
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.
Change From Baseline in Mean VA Score at 1 Year
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.
Change From Baseline in Mean VA Score at 2 Years
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.
Number of Participants Requiring Focal or Grid Laser Treatment During Year 1
Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation
Number of Participants Requiring Focal or Grid Laser Treatment During Year 2
Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation

Full Information

First Posted
January 18, 2008
Last Updated
October 18, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00605280
Brief Title
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.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema Associated With Diabetes Mellitus
Keywords
randomized sham-controlled multicenter macular edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
317 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham Control
Arm Type
Sham Comparator
Arm Title
Macugen
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Standard of Care
Intervention Description
Clinicians decision to use optional laser therapy.
Intervention Type
Drug
Intervention Name(s)
Macugen
Intervention Description
Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks up to 2 years.
Primary Outcome Measure Information:
Title
Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year
Description
Refraction and best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts
Time Frame
Baseline, Year 1
Secondary Outcome Measure Information:
Title
Number of Participants With a ≥ 10 Letter (or 2 Line) Improvement in Vision at 2 Years
Description
Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts
Time Frame
Baseline, Year 2
Title
Number of Participants With a ≥ 15 Letter Improvement in Vision at 1 Year
Description
Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts
Time Frame
Baseline, Year 1
Title
Number of Participants With a ≥ 15 Letter Improvement in Vision at 2 Years
Description
Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts
Time Frame
Baseline, Year 2
Title
Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 1 Year
Description
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.
Time Frame
Baseline, Year 1
Title
Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 1 Year
Description
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.
Time Frame
Baseline, Year 1
Title
Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 2 Years
Description
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.
Time Frame
Baseline, Year 2
Title
Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 2 Years
Description
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.
Time Frame
Baseline, Year 2
Title
Change From Baseline in Mean VA Score at 1 Year
Description
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.
Time Frame
Baseline, Year 1
Title
Change From Baseline in Mean VA Score at 2 Years
Description
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.
Time Frame
Baseline, Year 2
Title
Number of Participants Requiring Focal or Grid Laser Treatment During Year 1
Description
Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation
Time Frame
1 year
Title
Number of Participants Requiring Focal or Grid Laser Treatment During Year 2
Description
Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Pfizer Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Pfizer Investigational Site
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Pfizer Investigational Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Pfizer Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Pfizer Investigational Site
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Pfizer Investigational Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334-4146
Country
United States
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Pfizer Investigational Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Pfizer Investigational Site
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Pfizer Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46280
Country
United States
Facility Name
Pfizer Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Pfizer Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Pfizer Investigational Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1423
Country
United States
Facility Name
Pfizer Investigational Site
City
Lynbrook
State/Province
New York
ZIP/Postal Code
11563
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Pfizer Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Pfizer Investigational Site
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Pfizer Investigational Site
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Pfizer Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77002
Country
United States
Facility Name
Pfizer Investigational Site
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Pfizer Investigational Site
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Pfizer Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Pfizer Investigational Site
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Pfizer Investigational Site
City
East Melbourne
Country
Australia
Facility Name
Pfizer Investigational Site
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Pfizer Investigational Site
City
Wien
ZIP/Postal Code
A-1180
Country
Austria
Facility Name
Pfizer Investigational Site
City
Gioania
State/Province
GO
ZIP/Postal Code
74210-010
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Porto Alegre
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Sao Paolo
ZIP/Postal Code
SP 04524-20
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Sao Paulo
ZIP/Postal Code
04524-020
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3N9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2H1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Bogota
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Praha 6
ZIP/Postal Code
169 00
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Creteil
State/Province
Cedex
ZIP/Postal Code
94010
Country
France
Facility Name
Pfizer Investigational Site
City
Clermont
ZIP/Postal Code
63003
Country
France
Facility Name
Pfizer Investigational Site
City
Lyon
ZIP/Postal Code
69006
Country
France
Facility Name
Pfizer Investigational Site
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Pfizer Investigational Site
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Pfizer Investigational Site
City
Marsielle
ZIP/Postal Code
13008
Country
France
Facility Name
Pfizer Investigational Site
City
Nancy Cedex
ZIP/Postal Code
54035
Country
France
Facility Name
Pfizer Investigational Site
City
Paris Cedex 12
ZIP/Postal Code
75571
Country
France
Facility Name
Pfizer Investigational Site
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Pfizer Investigational Site
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Pfizer Investigational Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Pfizer Investigational Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Pfizer Investigational Site
City
Tuebingen
ZIP/Postal Code
72706
Country
Germany
Facility Name
Pfizer Investigational Site
City
Athens
ZIP/Postal Code
12462
Country
Greece
Facility Name
Pfizer Investigational Site
City
Ahmedabad
ZIP/Postal Code
380 004
Country
India
Facility Name
Pfizer Investigational Site
City
Bangalore
ZIP/Postal Code
560 085
Country
India
Facility Name
Pfizer Investigational Site
City
Hyderabad
ZIP/Postal Code
500 034
Country
India
Facility Name
Pfizer Investigational Site
City
New Delhi
ZIP/Postal Code
110 029
Country
India
Facility Name
Pfizer Investigational Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Pfizer Investigational Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Pfizer Investigational Site
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Nijmegen
ZIP/Postal Code
6500
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Coimbra
ZIP/Postal Code
3000-354
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21896838
Citation
Loftus JV, Sultan MB, Pleil AM; Macugen 1013 Study Group. Changes in vision- and health-related quality of life in patients with diabetic macular edema treated with pegaptanib sodium or sham. Invest Ophthalmol Vis Sci. 2011 Sep 29;52(10):7498-505. doi: 10.1167/iovs.11-7613.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5751013
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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.

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