Anti-vasculaR Endothelial Growth Factor plUs Anti-angiopoietin 2 in Fixed comBination therapY: Evaluation for the Treatment of Diabetic Macular Edema
NCT ID: NCT02712008
Last Updated: 2018-10-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
302 participants
INTERVENTIONAL
2016-03-02
2017-07-10
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
Co-formulation for intravitreal (IVT) injection consisting of REGN910 (nesvacumab) and REGN3 (aflibercept)
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 up to week 12.
REGN910-3
Co-formulation for intravitreal (IVT) injection consisting of REGN910 (nesvacumab) and REGN3 (aflibercept)
Aflibercept 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.
Intravitreal Aflibercept Injection (IAI)
REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q8
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) at Week 16 and Q8 through Week 32.
REGN910-3
Co-formulation for intravitreal (IVT) injection consisting of REGN910 (nesvacumab) and REGN3 (aflibercept)
REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q12
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) at Week 20 and Q12 through Week 32.
REGN910-3
Co-formulation for intravitreal (IVT) injection consisting of REGN910 (nesvacumab) and REGN3 (aflibercept)
Aflibercept 2 mg Q4 to Aflibercept 2 mg Q8
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 at Week16 and Q8 through Week 32.
Intravitreal Aflibercept Injection (IAI)
Aflibercept 2 mg Q4 to Aflibercept 2 mg Q12
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 at Week 20 and Q12 through Week 32.
Intravitreal Aflibercept Injection (IAI)
Aflibercept 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8
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 REGN910-3 (6 mg:2 mg) at week 16 and Q8 through week 32.
REGN910-3
Co-formulation for intravitreal (IVT) injection consisting of REGN910 (nesvacumab) and REGN3 (aflibercept)
Intravitreal Aflibercept Injection (IAI)
Interventions
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REGN910-3
Co-formulation for intravitreal (IVT) injection consisting of REGN910 (nesvacumab) and REGN3 (aflibercept)
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. IVT anti-VEGF in the study eye within 12 weeks of the screening visit
3. Panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening
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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Mesa, Arizona, United States
Tucson, Arizona, United States
Arcadia, California, United States
Beverly Hills, California, United States
Mountain View, California, United States
Oceanside, California, United States
Palm Desert, California, United States
Colorado Springs, Colorado, United States
New London, Connecticut, United States
Lakeland, Florida, United States
Tampa, Florida, United States
Winter Haven, Florida, United States
Augusta, Georgia, United States
Decatur, Georgia, United States
‘Aiea, Hawaii, United States
Chicago, Illinois, United States
New Albany, Indiana, United States
Shawnee Mission, Kansas, United States
Lexington, Kentucky, United States
Portland, Maine, United States
Baltimore, Maryland, United States
Rockville, Maryland, United States
Boston, Massachusetts, United States
Grand Rapids, Michigan, United States
Jackson, Michigan, United States
Minneapolis, Minnesota, United States
Florissant, Missouri, United States
Las Vegas, Nevada, United States
Bloomfield, New Jersey, United States
Edison, New Jersey, United States
Teaneck, New Jersey, United States
Albany, New York, United States
Rochester, New York, United States
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
Kingston, Pennsylvania, United States
Florence, South Carolina, United States
West Columbia, South Carolina, United States
Rapid City, South Dakota, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
Abilene, Texas, United States
Austin, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Harlingen, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
The Woodlands, Texas, United States
Willow Park, Texas, United States
Bellevue, Washington, 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-DME-1518
Identifier Type: -
Identifier Source: org_study_id
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