Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)
NCT ID: NCT00943072
Last Updated: 2013-05-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
189 participants
INTERVENTIONAL
2009-07-31
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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VEGF Trap-Eye
Monthly IVT injection of VEGF Trap-Eye 2.0 mg until Week 24 Primary Endpoint
VEGF Trap-Eye 2.0mg
Monthly intravitreal injection out to the Week 24 Primary endpoint
Sham
Monthly Sham IVT injection until Week 24 Primary Endpoint
Sham
Monthly sham intravitreal injection out to Week 24 Primary Endpoint
Interventions
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VEGF Trap-Eye 2.0mg
Monthly intravitreal injection out to the Week 24 Primary endpoint
Sham
Monthly sham intravitreal injection out to Week 24 Primary Endpoint
Eligibility Criteria
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Inclusion Criteria
* ETDRS best corrected visual acuity of 20/40 to 20/320 (73 to 24 letters) in the study eye
Exclusion Criteria
* Prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye
* CRVO disease duration \> 9 months from date of diagnosis
* Previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to Day 1
* Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Phoenix, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Arcadia, California, United States
Beverly Hills, California, United States
La Jolla, California, United States
Mountain View, California, United States
Oakland, California, United States
Sacramento, California, United States
Torrance, California, United States
New London, Connecticut, United States
Altamonte Springs, Florida, United States
Fort Lauderdale, Florida, United States
Fort Myers, Florida, United States
Fort Myers, Florida, United States
Miami, Florida, United States
Palm Beach Gardens, Florida, United States
Winter Haven, Florida, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
Wichita, Kansas, United States
Baltimore, Maryland, United States
Hagerstown, Maryland, United States
Towson, Maryland, United States
Boston, Massachusetts, United States
Grand Rapids, Michigan, United States
Jackson, Michigan, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
Northfield, New Jersey, United States
Toms River, New Jersey, United States
Rochester, New York, United States
Winston-Salem, North Carolina, United States
Cleveland, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Salem, Oregon, United States
Kingston, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
West Columbia, South Carolina, United States
Rapid City, South Dakota, United States
Nashville, Tennessee, United States
Abilene, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Halifax, Nova Scotia, Canada
London, Ontario, Canada
Mississauga, Ontario, Canada
Toronto, Ontario, Canada
Medellín, Antioquia, Colombia
Bogotá, , Colombia
Hyderabad, A.p., India
Bangalore, Karnataka, India
Kolkata, West Bengal, India
Kfar Saba, Israel, Israel
Petah Tikva, Israel, Israel
Rehovot, Israel, Israel
Tel Aviv, Israel, Israel
Countries
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Other Identifiers
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VGFT-OD-0819
Identifier Type: -
Identifier Source: org_study_id
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