Clinical trial NCT02712008: Anti-vasculaR Endothelial Growth Factor plUs Anti-angiopoietin 2 in Fixed comBination therapY: Evaluation for the Treatment of Diabetic Macular Edema
Official title: A Randomized, Double-Masked, Active-Controlled, Phase 2 Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal REGN910-3 in Patients With Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2016-03-17
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study was to compare the efficacy of intravitreal (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI) in improving best corrected visual acuity (BCVA) in participants with diabetic macular edema (DME).


Eligibility criteria: Key Inclusion Criteria:

1. Men or women ≥18 years of age with type 1 or type 2 diabetes mellitus who have clinically significant DME with central involvement in the study eye
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

Key Exclusion Criteria:

1. Evidence of macular edema due to any cause other than diabetes mellitus in either eye
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

Note: Other inclusion/ exclusion criteria apply

Primary outcomes:
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 36
timeFrame: Baseline, Week 36
Secondary outcomes:
measure: Change From Baseline in Central Sub-field Retinal Thickness (CST) Measured by Spectral Domain Optical Coherence Tomography (SD-OCT) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Central Sub-field Retinal Thickness (CST) Measured by Spectral Domain Optical Coherence Tomography (SD-OCT) at Week 36
timeFrame: Baseline, Week 36
measure: Percentage of Participants With a ≥ 2-step Improvement at Week 12 in Diabetic Retinopathy Severity Scale (DRSS) From Baseline
timeFrame: Baseline, Week 12
measure: Percentage of Participants With a ≥ 2-step Improvement at Week 36 in Diabetic Retinopathy Severity Scale (DRSS) From Baseline
timeFrame: Baseline, Week 36
Other outcomes:
Locations:
city: Mesa
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Arcadia
country: United States
state: California
city: Beverly Hills
country: United States
state: California
city: Mountain View
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Palm Desert
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: New London
country: United States
state: Connecticut
city: Lakeland
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Winter Haven
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: 'Aiea
country: United States
state: Hawaii
city: Chicago
country: United States
state: Illinois
city: New Albany
country: United States
state: Indiana
city: Shawnee Mission
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Portland
country: United States
state: Maine
city: Baltimore
country: United States
state: Maryland
city: Rockville
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Grand Rapids
country: United States
state: Michigan
city: Jackson
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Florissant
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Bloomfield
country: United States
state: New Jersey
city: Edison
country: United States
state: New Jersey
city: Teaneck
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Kingston
country: United States
state: Pennsylvania
city: Florence
country: United States
state: South Carolina
city: West Columbia
country: United States
state: South Carolina
city: Rapid City
country: United States
state: South Dakota
city: Germantown
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Abilene
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Harlingen
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: The Woodlands
country: United States
state: Texas
city: Willow Park
country: United States
state: Texas
city: Bellevue
country: United States
state: Washington
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: