Open-label Extension Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Neovascular ("Wet") Age-related Macular Degeneration (AMD)
NCT ID: NCT00964795
Last Updated: 2015-03-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
323 participants
INTERVENTIONAL
2009-12-31
2013-08-31
Brief Summary
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Detailed Description
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Participants will be seen in the clinic for quarterly visits starting with day 1 to assess safety. Study drug will be administered on an as-needed basis at the discretion of the investigator with a minimum allowed interval of every 4 weeks and a maximum allowed interval of every 12 weeks. This study will assess the frequency that re-treatment is needed and the effect of continued Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) treatment on BCVA.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open-label Intravitreal Aflibercept Injection
Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
Intravitreal Aflibercept Injection 2mg
Interventions
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Intravitreal Aflibercept Injection 2mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* In the opinion of the investigator, the study eye has neovascular AMD and may continue to require treatment.
Exclusion Criteria
* Females who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study.
50 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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Birmingham (2 Locations), Alabama, United States
Phoenix (2 Locations), Arizona, United States
Tucson (2 Locations), Arizona, United States
Arcadia, California, United States
Beverly Hills, California, United States
Campbell, California, United States
Fresno, California, United States
Fullerton, California, United States
La Jolla, California, United States
Loma Linda, California, United States
Mountain View, California, United States
Oakland, California, United States
Orange, California, United States
Palm Desert, California, United States
Sacramento, California, United States
San Mateo, California, United States
Santa Ana, California, United States
Torrance, California, United States
Westlake Village, California, United States
Yorba Linda, California, United States
Colorado Springs, Colorado, United States
Denver (2 Locations), Colorado, United States
Bridgeport, Connecticut, United States
New Haven, Connecticut, United States
New London, Connecticut, United States
Altamonte Springs, Florida, United States
Boynton Beach, Florida, United States
Fort Myers (2 Locations), Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando (2 Locations), Florida, United States
Oscala, Florida, United States
Palm Beach Gardens, Florida, United States
Pensacola, Florida, United States
Stuart, Florida, United States
Tampa, Florida, United States
Winter Haven, Florida, United States
Augusta, Georgia, United States
‘Aiea, Hawaii, United States
Glenview, Illinois, United States
Fort Wayne, Indiana, United States
Indianapolis, Indiana, United States
New Albany, Indiana, United States
Iowa City, Iowa, United States
Wichita, Kansas, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Bangor, Maine, United States
Portland, Maine, United States
Baltimore (3 Locations), Maryland, United States
Chevy Chase, Maryland, United States
Hagerstown, Maryland, United States
Boston (2 Locations), Massachusetts, United States
Peabody, Massachusetts, United States
Ann Arbor, Michigan, United States
Battle Creek, Michigan, United States
Grand Rapids, Michigan, United States
Jackson, Michigan, United States
Southfield, Michigan, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
Florissant, Missouri, United States
Kansas City, Missouri, United States
Springfield, Missouri, United States
St Louis, Missouri, United States
Missoula, Montana, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
Portsmouth, New Hampshire, United States
Lawrenceville, New Jersey, United States
Northfield, New Jersey, United States
Toms River, New Jersey, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Brooklyn, New York, United States
Lynbrook, New York, United States
New York (6 Locations), New York, United States
Rochester (2 Locations), New York, United States
Slingerlands, New York, United States
Syracuse, New York, United States
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Oklahoma City, Oklahoma, United States
Ashland, Oregon, United States
Portland (3 Locations), Oregon, United States
Salem, Oregon, United States
Kingston, Pennsylvania, United States
Philadelphia (3 Locations), Pennsylvania, United States
Pittsburgh (2 Locations), Pennsylvania, United States
West Mifflin, Pennsylvania, United States
Columbia, South Carolina, United States
Greenville, South Carolina, United States
West Columbia, South Carolina, United States
Rapid City, South Dakota, United States
Nashville, Tennessee, United States
Austin (3 Locations), Texas, United States
Dallas, Texas, United States
Fort Worth (2 Locations), Texas, United States
Houston, Texas, United States
McAllen, Texas, United States
Odessa, Texas, United States
San Antonio (2 Locations), Texas, United States
Tyler, Texas, United States
Salt Lake City (2 Locations), Utah, United States
Burlington, Vermont, United States
Charlottesville, Virginia, United States
Fairfax, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Madison (2 Locations), Wisconsin, United States
Milwaukee, Wisconsin, United States
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Halifax, Nova Scotia, Canada
London, Ontario, Canada
Mississauga, Ontario, Canada
Ottawa, Ontario, Canada
Montreal (2 Locations), Quebec, Canada
Regina, Saskatchewan, Canada
Countries
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Other Identifiers
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VGFT-OD-0910
Identifier Type: -
Identifier Source: org_study_id
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