Pegaptanib Sodium Compared to Sham Injection in Patients With Recent Vision Loss Due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)
A Phase II Randomized, Dose-Ranging, Double-Masked, Multi-Center Trial, in Parallel Groups, Determining Safety, Efficacy and PK of Intravitreous Injections of Pegaptanib Sodium Compared to Sham Injection for 30 Weeks in Patients With Recent Vision Loss Due to Macular Edema Secondary to CRVO
1 other identifier
interventional
90
1 country
35
Brief Summary
Eyetech Pharmaceuticals Inc. and Pfizer, Inc. are studying an investigational drug, MacugenTM, for the possible treatment of CRVO. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). This investigational drug may slow the growth of abnormal blood vessels in the eye and may reduce tissue swelling in the eye. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 23, 2004
CompletedFirst Posted
Study publicly available on registry
July 26, 2004
CompletedJanuary 19, 2007
January 1, 2007
July 23, 2004
January 17, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- CRVO must have occurred within the past 6 months and be associated with macular edema determined by OCT.
- 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.
You may not qualify if:
- Presence of signs of old branch retinal vein occlusion (BRVO) or CRVO in the study eye or any other retinal vascular disease including diabetic retinopathy.
- Vitreous hemorrhage except breakthrough hemorrhage from intraretinal hemorrhage.
- Prior pan retinal photocoagulation (PRP) or sector scatter photocoagulation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eyetech Pharmaceuticalslead
- Pfizercollaborator
Study Sites (35)
Retina Centers, P.C., Northwest Location
Tucson, Arizona, 85704, United States
Retina Associates, SW
Tucson, Arizona, 85710, United States
Jules Stein Institute
Los Angeles, California, 90095, United States
Orange County Retina Associates
Santa Ana, California, 92705, United States
New England Retina Associates
Hamden, Connecticut, 06518, United States
Retina Group of Florida
Fort Lauderdale, Florida, 33334, United States
Bascom Palmer Eye Institute
Miami, Florida, 33136, United States
The University of Chicago
Chicago, Illinois, 60637, United States
Macula-Retina-Vitreous Service
Indianapolis, Indiana, 46280, United States
Vitreo-Retinal Consultants & Surgeons, P.A.
Wichita, Kansas, 67214, United States
Retina Associates
New Orleans, Louisiana, 70155, United States
Retina Group of Washington
Chevy Chase, Maryland, 20815, United States
Cumberland Valley Retina Center
Hagerstown, Maryland, 21740, United States
New England Eye Center
Boston, Massachusetts, 02111, United States
Massachusetts Eye & Ear Infirmary
Boston, Massachusetts, 02114, United States
Lahey Clinic, The Eye Institute
Peabody, Massachusetts, 01960, United States
Kresge Eye Institute
Detroit, Michigan, 48201, United States
Associated Retinal Consultants
Royal Oak, Michigan, 48073, United States
Eye Foundation of Kansas City
Kansas City, Missouri, 64108, United States
Charlotte Eye, Ear, Nose and Throat Associates, P.A.
Charlotte, North Carolina, 28210, United States
Duke University Eye Center
Durham, North Carolina, 27710, United States
The Cleveland Clinic
Cleveland, Ohio, 44195, United States
Retina Associates of Cleveland Inc.
Lakewood, Ohio, 44107, United States
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, 73104, United States
Casey Eye Institute
Portland, Oregon, 97239, United States
Wills Eye Institute Retina Research
Philadelphia, Pennsylvania, 19107, United States
Palmetto Retina Center
Columbia, South Carolina, 29204, United States
Southeastern Retina Associates
Knoxville, Tennessee, 37909, United States
Retina Research Institute of Texas, LLC
Abilene, Texas, 79606, United States
Austin Retina Associates
Austin, Texas, 78705, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
VitreoRetinal Consultants
Houston, Texas, 77030, United States
Valley Retina Associates, P.A.
McAllen, Texas, 78503, United States
University of Wisconsin
Madison, Wisconsin, 53705, United States
The Eye Institute
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
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.
PMID: 19365011DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 23, 2004
First Posted
July 26, 2004
Study Start
May 1, 2004
Last Updated
January 19, 2007
Record last verified: 2007-01