Anti-angiOpoeitin 2 Plus Anti-vascular eNdothelial Growth Factor as a therapY for Neovascular Age Related Macular Degeneration: Evaluation of a fiXed Combination Intravitreal Injection
NCT ID: NCT02713204
Last Updated: 2019-05-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
365 participants
INTERVENTIONAL
2016-03-31
2017-10-03
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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REGN910-3 (3 mg: 2 mg)
Participants were administered intravitreal injection of REGN910-3 (3 milligram \[mg\]:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 up to Week 32.
REGN910-3
REGN910-3 (6 mg:2 mg)
Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 or Q12 (beginning at Week 16 or Week 20) through Week 32.
REGN910-3
Aflibercept (IAI) 2 mg
Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.
REGN910-3
Intravitreal Aflibercept Injection (IAI)
Interventions
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REGN910-3
Intravitreal Aflibercept Injection (IAI)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. BCVA ETDRS letter score of 73 to 24 (Snellen equivalent of 20/40 to 20/320) in the study eye.
3. Willing and able to comply with clinic visits and study-related procedures.
4. Provide signed informed consent.
Exclusion Criteria
2. Prior IVT anti-VEGF in the study eye
3. Evidence of DME or diabetic retinopathy (defined as more than 1 microaneurysm) in either eye in diabetic patients
4. Any history of macular hole of stage 2 and above in the study eye
50 Years
ALL
No
Sponsors
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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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Regeneron Investigational Site
Mobile, Alabama, United States
Regeneron Investigational Site 1
Phoenix, Arizona, United States
Regeneron Investigational Site 2
Phoenix, Arizona, United States
Regeneron Investigational Site 3
Phoenix, Arizona, United States
Regeneron Investigational Site 1
Tucson, Arizona, United States
Regeneron Investigational Site 2
Tucson, Arizona, United States
Regeneron Investigational Site
Arcadia, California, United States
Regeneron Investigational Site
Bakersfield, California, United States
Regeneron Investigational Site
Beverly Hills, California, United States
Regeneron Investigational Site
Encino, California, United States
Regeneron Investigational Site 1
Los Angeles, California, United States
Regeneron Investigational Site 2
Los Angeles, California, United States
Regeneron Investigational Site
Mountain View, California, United States
Regeneron Investigational Site
Oceanside, California, United States
Regeneron Investigational Site 1
Palm Desert, California, United States
Regeneron Investigational Site 2
Palm Desert, California, United States
Regeneron Investigational Site
Palo Alto, California, United States
Regeneron Investigational Site
Poway, California, United States
Regeneron Investigational Site
Redlands, California, United States
Regeneron Investigational Site
Sacramento, California, United States
Regeneron Investigational Site
Santa Maria, California, United States
Regeneron Investigational Site
New London, Connecticut, United States
Regeneron Investigational Site
Altamonte Springs, Florida, United States
Regeneron Investigational Site
Fort Lauderdale, Florida, United States
Regeneron Investigational Site
Lakeland, Florida, United States
Regeneron Investigational Site
Largo, Florida, United States
Regeneron Investigational Site
Miami, Florida, United States
Regeneron Investigational Site
Naples, Florida, United States
Regeneron Investigational Site
Palm Beach, Florida, United States
Regeneron Investigational Site
Tallahassee, Florida, United States
Regeneron Investigational Site
Winter Haven, Florida, United States
Regeneron Investigational Site
Augusta, Georgia, United States
Regeneron Investigational Site
Decatur, Georgia, United States
Regeneron Investigational Site
‘Aiea, Hawaii, United States
Regeneron Investigational Site 1
Chicago, Illinois, United States
Regeneron Investigational Site 2
Chicago, Illinois, United States
Regeneron Investigational Site
Lemont, Illinois, United States
Regeneron Investigational Site
Oak Forest, Illinois, United States
Regeneron Investigational Site
Oak Park, Illinois, United States
Regeneron Investigational Site
Urbana, Illinois, United States
Regeneron Investigational Site
New Albany, Indiana, United States
Regeneron Investigational Site
Des Moines, Iowa, United States
Regeneron Investigational Site
Metairie, Louisiana, United States
Regeneron Investigational Site 1
Baltimore, Maryland, United States
Regeneron Investigational Site 2
Baltimore, Maryland, United States
Regeneron Investigational Site
Chevy Chase, Maryland, United States
Regeneron Investigational Site 1
Boston, Massachusetts, United States
Regeneron Investigational Site 2
Boston, Massachusetts, United States
Regeneron Investigational Site
Jackson, Michigan, United States
Regeneron Investigational Site
Minneapolis, Minnesota, United States
Regeneron Investigational Site
St Louis, Missouri, United States
Regeneron Investigational Site
Las Vegas, Nevada, United States
Regeneron Investigational Site
Portsmouth, New Hampshire, United States
Regeneron Investigational Site
Edison, New Jersey, United States
Regeneron Investigational Site
Teaneck, New Jersey, United States
Regeneron Investigational Site
Albuquerque, New Mexico, United States
Regeneron Investigational Site
Albany, New York, United States
Regeneron Investigational Site
Bloomfield, New York, United States
Regeneron Investigational Site
Great Neck, New York, United States
Regeneron Investigational Site
Hauppauge, New York, United States
Regeneron Investigational Site
Rochester, New York, United States
Regeneron Investigational Site
Syracuse, New York, United States
Regeneron Investigational Site
Asheville, North Carolina, United States
Regeneron Investigational Site
Charlotte, North Carolina, United States
Regeneron Investigational Site
Durham, North Carolina, United States
Regeneron Investigational Site
Cleveland, Ohio, United States
Regeneron Investigational Site
Dublin, Ohio, United States
Regeneron Investigational Site
Portland, Oregon, United States
Regeneron Investigational Site
Camp Hill, Pennsylvania, United States
Regeneron Investigational Site
Huntingdon, Pennsylvania, United States
Regeneron Investigational Site
Ladson, South Carolina, United States
Regeneron Investigational Site
Rapid City, South Dakota, United States
Regeneron Investigational Site
Germantown, Tennessee, United States
Regeneron Investigational Site
Knoxville, Tennessee, United States
Regeneron Investigational Site
Nashville, Tennessee, United States
Regeneron Investigational Site
Abilene, Texas, United States
Regeneron Investigational Site 1
Austin, Texas, United States
Regeneron Investigational Site 2
Austin, Texas, United States
Regeneron Investigational Site
Dallas, Texas, United States
Regeneron Investigational Site 1
Fort Worth, Texas, United States
Regeneron Investigational Site 2
Fort Worth, Texas, United States
Regeneron Investigational Site
Harlingen, Texas, United States
Regeneron Investigational Site
Houston, Texas, United States
Regeneron Investigational Site
The Woodlands, Texas, United States
Regeneron Investigational Site
Willow Park, Texas, United States
Regeneron Investigational Site
Salt Lake City, Utah, United States
Regeneron Investigational Site
Madison, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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R910-3-AMD-1517
Identifier Type: -
Identifier Source: org_study_id
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