Pegaptanib Sodium Compared to Sham Injection in Patients With Recent Vision Loss Due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)
- Conditions
- Retinal Vein Occlusion
- Registration Number
- NCT00088283
- Lead Sponsor
- Eyetech Pharmaceuticals
- 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.
- Detailed Description
This study will consist of 3 phases: a screening phase which will last up to two weeks, a confirmation phase which will last one day, and a randomization phase (the patient will be assigned by chance to a study group in this phase) which will last approximately 52 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (35)
Jules Stein Institute
🇺🇸Los Angeles, California, United States
Orange County Retina Associates
🇺🇸Santa Ana, California, United States
Cumberland Valley Retina Center
🇺🇸Hagerstown, Maryland, United States
New England Eye Center
🇺🇸Boston, Massachusetts, United States
The Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Texas Retina Associates
🇺🇸Dallas, Texas, United States
VitreoRetinal Consultants
🇺🇸Houston, Texas, United States
The University of Chicago
🇺🇸Chicago, Illinois, United States
Associated Retinal Consultants
🇺🇸Royal Oak, Michigan, United States
Bascom Palmer Eye Institute
🇺🇸Miami, Florida, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Retina Centers, P.C., Northwest Location
🇺🇸Tucson, Arizona, United States
Retina Associates, SW
🇺🇸Tucson, Arizona, United States
New England Retina Associates
🇺🇸Hamden, Connecticut, United States
Retina Associates
🇺🇸New Orleans, Louisiana, United States
Retina Group of Florida
🇺🇸Fort Lauderdale, Florida, United States
Lahey Clinic, The Eye Institute
🇺🇸Peabody, Massachusetts, United States
Southeastern Retina Associates
🇺🇸Knoxville, Tennessee, United States
Kresge Eye Institute
🇺🇸Detroit, Michigan, United States
Duke University Eye Center
🇺🇸Durham, North Carolina, United States
Dean A. McGee Eye Institute
🇺🇸Oklahoma City, Oklahoma, United States
Casey Eye Institute
🇺🇸Portland, Oregon, United States
The Eye Institute
🇺🇸Milwaukee, Wisconsin, United States
Vitreo-Retinal Consultants & Surgeons, P.A.
🇺🇸Wichita, Kansas, United States
Eye Foundation of Kansas City
🇺🇸Kansas City, Missouri, United States
Austin Retina Associates
🇺🇸Austin, Texas, United States
Massachusetts Eye & Ear Infirmary
🇺🇸Boston, Massachusetts, United States
Retina Group of Washington
🇺🇸Chevy Chase, Maryland, United States
Charlotte Eye, Ear, Nose and Throat Associates, P.A.
🇺🇸Charlotte, North Carolina, United States
Wills Eye Institute Retina Research
🇺🇸Philadelphia, Pennsylvania, United States
Retina Associates of Cleveland Inc.
🇺🇸Lakewood, Ohio, United States
Palmetto Retina Center
🇺🇸Columbia, South Carolina, United States
Retina Research Institute of Texas, LLC
🇺🇸Abilene, Texas, United States
Macula-Retina-Vitreous Service
🇺🇸Indianapolis, Indiana, United States
Valley Retina Associates, P.A.
🇺🇸McAllen, Texas, United States