Pegaptanib Sodium Compared to Sham Injection in Patients With Recent Vision Loss Due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)
NCT ID: NCT00088283
Last Updated: 2007-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2004-05-31
Brief Summary
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The purpose of this study is to compare the safety and efficacy of a Macugen™ injection to a "pretend" injection. In addition, the purpose of this study is to measure the action of the study drug in the body over a period of time and to check for the presence of the study drug in your blood (called pharmacokinetics or PK).
This study will involve approximately 90 people. People who decide to participate will have an equal chance (1 in 3) to receive one of three study injections, two of which are Macugen™ and one of which is a "pretend" injection.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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pegaptanib sodium
Eligibility Criteria
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Inclusion Criteria
* Vision in the study eye corresponding to between approximately 20/50 to 20/400 and better than or equal to approximately 20/200 in the fellow eye.
Exclusion Criteria
* Vitreous hemorrhage except breakthrough hemorrhage from intraretinal hemorrhage.
* Prior pan retinal photocoagulation (PRP) or sector scatter photocoagulation.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Eyetech Pharmaceuticals
INDUSTRY
Locations
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Retina Centers, P.C., Northwest Location
Tucson, Arizona, United States
Retina Associates, SW
Tucson, Arizona, United States
Jules Stein Institute
Los Angeles, California, United States
Orange County Retina Associates
Santa Ana, California, United States
New England Retina Associates
Hamden, Connecticut, United States
Retina Group of Florida
Fort Lauderdale, Florida, United States
Bascom Palmer Eye Institute
Miami, Florida, United States
The University of Chicago
Chicago, Illinois, United States
Macula-Retina-Vitreous Service
Indianapolis, Indiana, United States
Vitreo-Retinal Consultants & Surgeons, P.A.
Wichita, Kansas, United States
Retina Associates
New Orleans, Louisiana, United States
Retina Group of Washington
Chevy Chase, Maryland, United States
Cumberland Valley Retina Center
Hagerstown, Maryland, United States
New England Eye Center
Boston, Massachusetts, United States
Massachusetts Eye & Ear Infirmary
Boston, Massachusetts, United States
Lahey Clinic, The Eye Institute
Peabody, Massachusetts, United States
Kresge Eye Institute
Detroit, Michigan, United States
Associated Retinal Consultants
Royal Oak, Michigan, United States
Eye Foundation of Kansas City
Kansas City, Missouri, United States
Charlotte Eye, Ear, Nose and Throat Associates, P.A.
Charlotte, North Carolina, United States
Duke University Eye Center
Durham, North Carolina, United States
The Cleveland Clinic
Cleveland, Ohio, United States
Retina Associates of Cleveland Inc.
Lakewood, Ohio, United States
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, United States
Casey Eye Institute
Portland, Oregon, United States
Wills Eye Institute Retina Research
Philadelphia, Pennsylvania, United States
Palmetto Retina Center
Columbia, South Carolina, United States
Southeastern Retina Associates
Knoxville, Tennessee, United States
Retina Research Institute of Texas, LLC
Abilene, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Texas Retina Associates
Dallas, Texas, United States
VitreoRetinal Consultants
Houston, Texas, United States
Valley Retina Associates, P.A.
McAllen, Texas, United States
University of Wisconsin
Madison, Wisconsin, United States
The Eye Institute
Milwaukee, Wisconsin, United States
Countries
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References
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Wroblewski JJ, Wells JA 3rd, Adamis AP, Buggage RR, Cunningham ET Jr, Goldbaum M, Guyer DR, Katz B, Altaweel MM; Pegaptanib in Central Retinal Vein Occlusion Study Group. Pegaptanib sodium for macular edema secondary to central retinal vein occlusion. Arch Ophthalmol. 2009 Apr;127(4):374-80. doi: 10.1001/archophthalmol.2009.14.
Related Links
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Sponsor's Website
Other Identifiers
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EOP 1011B
Identifier Type: -
Identifier Source: org_study_id
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