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.
NCT ID: NCT00605280
Last Updated: 2018-11-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
317 participants
INTERVENTIONAL
2005-09-30
2011-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pegaptanib Sodium Compared to Sham Injection in Patients With DME Involving the Center of the Macula
NCT00040313
Pegaptanib for Retinal Edema Secondary to Diabetic Vascular Disease(Preserve) Study
NCT01486238
A Single-Center Trial of High Frequency Pegaptanib for Rapid Restoration of VEGF Levels in Diabetic Retinal Edema
NCT01487044
Study of the Safety, Tolerability and Pharmacokinetics of 1 Mg/Eye and 3 Mg/Eye Pegaptanib Sodium in Patients With Exudative Age-Related Macular Degeneration (AMD)
NCT00215670
Macugen for Proliferative Diabetic Retinopathy Study With Extended Dosing (M-PDRS ED)
NCT01486771
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sham Control
Standard of Care
Clinicians decision to use optional laser therapy.
Macugen
Macugen
Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks up to 2 years.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Standard of Care
Clinicians decision to use optional laser therapy.
Macugen
Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks up to 2 years.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* visual acuity between 20/50 and 20/200
Exclusion Criteria
* recent signs of uncontrolled diabetes
* blood pressure worse than 160/100
* severe cardiac disease
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Tucson, Arizona, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Oakland, California, United States
Pfizer Investigational Site
Santa Ana, California, United States
Pfizer Investigational Site
Denver, Colorado, United States
Pfizer Investigational Site
Hamden, Connecticut, United States
Pfizer Investigational Site
Fort Lauderdale, Florida, United States
Pfizer Investigational Site
Tampa, Florida, United States
Pfizer Investigational Site
Tampa, Florida, United States
Pfizer Investigational Site
Augusta, Georgia, United States
Pfizer Investigational Site
‘Aiea, Hawaii, United States
Pfizer Investigational Site
Indianapolis, Indiana, United States
Pfizer Investigational Site
Wichita, Kansas, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Detroit, Michigan, United States
Pfizer Investigational Site
Lynbrook, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Charlotte, North Carolina, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States
Pfizer Investigational Site
West Columbia, South Carolina, United States
Pfizer Investigational Site
Abilene, Texas, United States
Pfizer Investigational Site
Fort Worth, Texas, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
McAllen, Texas, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Pfizer Investigational Site
Temple, Texas, United States
Pfizer Investigational Site
Milwaukee, Wisconsin, United States
Pfizer Investigational Site
Westmead, New South Wales, Australia
Pfizer Investigational Site
East Melbourne, , Australia
Pfizer Investigational Site
Innsbruck, , Austria
Pfizer Investigational Site
Vienna, , Austria
Pfizer Investigational Site
Gioania, Goiás, Brazil
Pfizer Investigational Site
Porto Alegre, , Brazil
Pfizer Investigational Site
São Paulo, , Brazil
Pfizer Investigational Site
São Paulo, , Brazil
Pfizer Investigational Site
Vancouver, British Columbia, Canada
Pfizer Investigational Site
Montreal, Quebec, Canada
Pfizer Investigational Site
Bogotá, , Colombia
Pfizer Investigational Site
Brno, , Czechia
Pfizer Investigational Site
Hradec Králové, , Czechia
Pfizer Investigational Site
Olomouc, , Czechia
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Glostrup Municipality, , Denmark
Pfizer Investigational Site
Créteil, Cedex, France
Pfizer Investigational Site
Clermont, , France
Pfizer Investigational Site
Lyon, , France
Pfizer Investigational Site
Marseille, , France
Pfizer Investigational Site
Marseille, , France
Pfizer Investigational Site
Marsielle, , France
Pfizer Investigational Site
Nancy, , France
Pfizer Investigational Site
Paris, , France
Pfizer Investigational Site
Bonn, , Germany
Pfizer Investigational Site
Düsseldorf, , Germany
Pfizer Investigational Site
Heidelberg, , Germany
Pfizer Investigational Site
Leipzig, , Germany
Pfizer Investigational Site
Münster, , Germany
Pfizer Investigational Site
Tübingen, , Germany
Pfizer Investigational Site
Athens, , Greece
Pfizer Investigational Site
Ahmedabad, , India
Pfizer Investigational Site
Bangalore, , India
Pfizer Investigational Site
Hyderabad, , India
Pfizer Investigational Site
New Delhi, , India
Pfizer Investigational Site
Florence, , Italy
Pfizer Investigational Site
Milan, , Italy
Pfizer Investigational Site
Udine, , Italy
Pfizer Investigational Site
Nijmegen, , Netherlands
Pfizer Investigational Site
Coimbra, , Portugal
Pfizer Investigational Site
Bloemfontein, , South Africa
Pfizer Investigational Site
Bern, , Switzerland
Pfizer Investigational Site
Newcastle upon Tyne, , United Kingdom
Pfizer Investigational Site
Sheffield, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EOP1013H
Identifier Type: -
Identifier Source: secondary_id
A5751013
Identifier Type: -
Identifier Source: org_study_id
NCT00148811
Identifier Type: -
Identifier Source: nct_alias
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.