Clinical trial NCT00605280: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Macular Edema Associated With Diabetes Mellitus
Keywords: randomized sham-controlled multicenter macular edema
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-01-31
Enrollment: 317
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year
timeFrame: Baseline, Year 1
Secondary outcomes:
measure: Number of Participants With a ≥ 10 Letter (or 2 Line) Improvement in Vision at 2 Years
timeFrame: Baseline, Year 2
measure: Number of Participants With a ≥ 15 Letter Improvement in Vision at 1 Year
timeFrame: Baseline, Year 1
measure: Number of Participants With a ≥ 15 Letter Improvement in Vision at 2 Years
timeFrame: Baseline, Year 2
measure: Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 1 Year
timeFrame: Baseline, Year 1
measure: Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 1 Year
timeFrame: Baseline, Year 1
measure: Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 2 Years
timeFrame: Baseline, Year 2
measure: Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 2 Years
timeFrame: Baseline, Year 2
measure: Change From Baseline in Mean VA Score at 1 Year
timeFrame: Baseline, Year 1
measure: Change From Baseline in Mean VA Score at 2 Years
timeFrame: Baseline, Year 2
measure: Number of Participants Requiring Focal or Grid Laser Treatment During Year 1
timeFrame: 1 year
measure: Number of Participants Requiring Focal or Grid Laser Treatment During Year 2
timeFrame: 2 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Oakland
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Ana
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Hamden
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Augusta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: 'Aiea
country: United States
facility: Pfizer Investigational Site
state: Hawaii
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Detroit
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Lynbrook
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: West Columbia
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Abilene
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: McAllen
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Temple
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Westmead
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: East Melbourne
country: Australia
facility: Pfizer Investigational Site
city: Innsbruck
country: Austria
facility: Pfizer Investigational Site
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Gioania
country: Brazil
facility: Pfizer Investigational Site
state: GO
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
city: Sao Paolo
country: Brazil
facility: Pfizer Investigational Site
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
city: Brno
country: Czechia
facility: Pfizer Investigational Site
city: Hradec Kralove
country: Czechia
facility: Pfizer Investigational Site
city: Olomouc
country: Czechia
facility: Pfizer Investigational Site
city: Praha 4
country: Czechia
facility: Pfizer Investigational Site
city: Praha 6
country: Czechia
facility: Pfizer Investigational Site
city: Glostrup
country: Denmark
facility: Pfizer Investigational Site
city: Creteil
country: France
facility: Pfizer Investigational Site
state: Cedex
city: Clermont
country: France
facility: Pfizer Investigational Site
city: Lyon
country: France
facility: Pfizer Investigational Site
city: Marseille Cedex 5
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Marsielle
country: France
facility: Pfizer Investigational Site
city: Nancy Cedex
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 12
country: France
facility: Pfizer Investigational Site
city: Bonn
country: Germany
facility: Pfizer Investigational Site
city: Duesseldorf
country: Germany
facility: Pfizer Investigational Site
city: Heidelberg
country: Germany
facility: Pfizer Investigational Site
city: Leipzig
country: Germany
facility: Pfizer Investigational Site
city: Muenster
country: Germany
facility: Pfizer Investigational Site
city: Tuebingen
country: Germany
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Ahmedabad
country: India
facility: Pfizer Investigational Site
city: Bangalore
country: India
facility: Pfizer Investigational Site
city: Hyderabad
country: India
facility: Pfizer Investigational Site
city: New Delhi
country: India
facility: Pfizer Investigational Site
city: Firenze
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Udine
country: Italy
facility: Pfizer Investigational Site
city: Nijmegen
country: Netherlands
facility: Pfizer Investigational Site
city: Coimbra
country: Portugal
facility: Pfizer Investigational Site
city: Bloemfontein
country: South Africa
facility: Pfizer Investigational Site
city: Bern
country: Switzerland
facility: Pfizer Investigational Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Pfizer Investigational Site
city: Sheffield
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.