DME And VEGF Trap-Eye [Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)] INvestigation of Clinical Impact
NCT ID: NCT00789477
Last Updated: 2014-09-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
221 participants
INTERVENTIONAL
2008-12-31
2010-09-30
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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Intravitreal Aflibercept Injection .5Q4
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) .5 mg every 4 weeks
Intravitreal Aflibercept Injection
Intravitreal Aflibercept Injection 2Q4
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2 mg every 4 weeks
Intravitreal Aflibercept Injection
Intravitreal Aflibercept Injection 2Q8
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by every 8 weeks
Intravitreal Aflibercept Injection
Intravitreal Aflibercept Injection 2PRN
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by PRN (as-needed) dosing according to the re-treatment criteria
Intravitreal Aflibercept Injection
Laser Photocoagulation
Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
Laser Photocoagulation
laser every 16 weeks as needed
Interventions
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Laser Photocoagulation
laser every 16 weeks as needed
Intravitreal Aflibercept Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adults 18 years or older with type 1 or 2 diabetes mellitus with diabetic macular edema
* ETDRS BCVA: 20/40 to 20/320 (letter score of 73 to 24) in the study eye
Exclusion Criteria
* Panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening
* Previous use of intraocular or periocular corticosteroids in the study eye within 3 months of screening
* Previous treatment with anti-angiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc) within 3 months of screening
* Uncontrolled diabetes mellitus
* Uncontrolled hypertension defined as systolic \> 180mmHg or \> 160 mmHg on 2 consecutive measurements or diastolic \> 100 mmHg on optimal medical regimen
* Ocular disorders in the study eye, other than DME, that may confound interpretation of study results
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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Artesia, California, United States
Beverly Hills, California, United States
Mountain View, California, United States
Pasadena, California, United States
Sacramento, California, United States
Santa Ana, California, United States
Hamden, Connecticut, United States
New London, Connecticut, United States
Boynton Beach, Florida, United States
Fort Lauderdale, Florida, United States
Fort Myers, Florida, United States
Ocala, Florida, United States
Palm Beach Gardens, Florida, United States
Winter Haven, Florida, United States
Augusta, Georgia, United States
Honolulu, Hawaii, United States
Indianapolis, Indiana, United States
Bangor, Maine, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Jackson, Michigan, United States
Kansas City, Missouri, United States
Lincoln, Nebraska, United States
New Brunswick, New Jersey, United States
Northfield, New Jersey, United States
Toms River, New Jersey, United States
Rochester, New York, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Pittsburgh, Pennsylvania, United States
Greenville, South Carolina, United States
West Columbia, South Carolina, United States
Nashville, Tennessee, United States
Abilene, Texas, United States
Arlington, Texas, United States
Austin, Texas, United States
Houston, Texas, United States
McAllen, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Vienna, , Austria
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
London, Ontario, Canada
Mississauga, Ontario, Canada
Countries
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Other Identifiers
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VGFT-OD-0706
Identifier Type: -
Identifier Source: org_study_id
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