Clinical trial NCT02713204: 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
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 Neovascular Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neovascular Age-Related Macular Degeneration
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-03-18
Enrollment: 365
Sex: ALL
Minimum age (years): 50
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 is to compare the efficacy of intravitreal (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI).


Eligibility criteria: Key Inclusion Criteria:

1. Men or women ≥50 years of age with active subfoveal CNV secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye as assessed by a central reading center
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 CNV due to any cause other than AMD in either eye
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

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: At 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: At 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: At 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: At Week 36
measure: Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 12
timeFrame: At Week 12
measure: Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 36
timeFrame: At Week 36
measure: Change From Baseline in Total Lesion Area at Week 12
timeFrame: At Week 12
measure: Change From Baseline in Total Lesion Area at Week 36
timeFrame: At Week 36
Other outcomes:
measure: Proportion of Participants With No Retinal and/or Subretinal Fluid at Week 12
timeFrame: At Week 12
measure: Proportion of Participants With No Retinal and/or Subretinal Fluid From Baseline Through Week 36
timeFrame: Baseline through Week 36
measure: Time to No Retinal and/or Subretinal Fluid Through Week 36
timeFrame: Baseline through Week 36
Locations:
city: Mobile
country: United States
facility: Regeneron Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Regeneron Investigational Site 1
state: Arizona
city: Phoenix
country: United States
facility: Regeneron Investigational Site 2
state: Arizona
city: Phoenix
country: United States
facility: Regeneron Investigational Site 3
state: Arizona
city: Tucson
country: United States
facility: Regeneron Investigational Site 1
state: Arizona
city: Tucson
country: United States
facility: Regeneron Investigational Site 2
state: Arizona
city: Arcadia
country: United States
facility: Regeneron Investigational Site
state: California
city: Bakersfield
country: United States
facility: Regeneron Investigational Site
state: California
city: Beverly Hills
country: United States
facility: Regeneron Investigational Site
state: California
city: Encino
country: United States
facility: Regeneron Investigational Site
state: California
city: Los Angeles
country: United States
facility: Regeneron Investigational Site 1
state: California
city: Los Angeles
country: United States
facility: Regeneron Investigational Site 2
state: California
city: Mountain View
country: United States
facility: Regeneron Investigational Site
state: California
city: Oceanside
country: United States
facility: Regeneron Investigational Site
state: California
city: Palm Desert
country: United States
facility: Regeneron Investigational Site 1
state: California
city: Palm Desert
country: United States
facility: Regeneron Investigational Site 2
state: California
city: Palo Alto
country: United States
facility: Regeneron Investigational Site
state: California
city: Poway
country: United States
facility: Regeneron Investigational Site
state: California
city: Redlands
country: United States
facility: Regeneron Investigational Site
state: California
city: Sacramento
country: United States
facility: Regeneron Investigational Site
state: California
city: Santa Maria
country: United States
facility: Regeneron Investigational Site
state: California
city: New London
country: United States
facility: Regeneron Investigational Site
state: Connecticut
city: Altamonte Springs
country: United States
facility: Regeneron Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Regeneron Investigational Site
state: Florida
city: Lakeland
country: United States
facility: Regeneron Investigational Site
state: Florida
city: Largo
country: United States
facility: Regeneron Investigational Site
state: Florida
city: Miami
country: United States
facility: Regeneron Investigational Site
state: Florida
city: Naples
country: United States
facility: Regeneron Investigational Site
state: Florida
city: Palm Beach
country: United States
facility: Regeneron Investigational Site
state: Florida
city: Tallahassee
country: United States
facility: Regeneron Investigational Site
state: Florida
city: Winter Haven
country: United States
facility: Regeneron Investigational Site
state: Florida
city: Augusta
country: United States
facility: Regeneron Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Regeneron Investigational Site
state: Georgia
city: 'Aiea
country: United States
facility: Regeneron Investigational Site
state: Hawaii
city: Chicago
country: United States
facility: Regeneron Investigational Site 1
state: Illinois
city: Chicago
country: United States
facility: Regeneron Investigational Site 2
state: Illinois
city: Lemont
country: United States
facility: Regeneron Investigational Site
state: Illinois
city: Oak Forest
country: United States
facility: Regeneron Investigational Site
state: Illinois
city: Oak Park
country: United States
facility: Regeneron Investigational Site
state: Illinois
city: Urbana
country: United States
facility: Regeneron Investigational Site
state: Illinois
city: New Albany
country: United States
facility: Regeneron Investigational Site
state: Indiana
city: Des Moines
country: United States
facility: Regeneron Investigational Site
state: Iowa
city: Metairie
country: United States
facility: Regeneron Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Regeneron Investigational Site 1
state: Maryland
city: Baltimore
country: United States
facility: Regeneron Investigational Site 2
state: Maryland
city: Chevy Chase
country: United States
facility: Regeneron Investigational Site
state: Maryland
city: Boston
country: United States
facility: Regeneron Investigational Site 1
state: Massachusetts
city: Boston
country: United States
facility: Regeneron Investigational Site 2
state: Massachusetts
city: Jackson
country: United States
facility: Regeneron Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: Regeneron Investigational Site
state: Minnesota
city: Saint Louis
country: United States
facility: Regeneron Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Regeneron Investigational Site
state: Nevada
city: Portsmouth
country: United States
facility: Regeneron Investigational Site
state: New Hampshire
city: Edison
country: United States
facility: Regeneron Investigational Site
state: New Jersey
city: Teaneck
country: United States
facility: Regeneron Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Regeneron Investigational Site
state: New Mexico
city: Albany
country: United States
facility: Regeneron Investigational Site
state: New York
city: Bloomfield
country: United States
facility: Regeneron Investigational Site
state: New York
city: Great Neck
country: United States
facility: Regeneron Investigational Site
state: New York
city: Hauppauge
country: United States
facility: Regeneron Investigational Site
state: New York
city: Rochester
country: United States
facility: Regeneron Investigational Site
state: New York
city: Syracuse
country: United States
facility: Regeneron Investigational Site
state: New York
city: Asheville
country: United States
facility: Regeneron Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Regeneron Investigational Site
state: North Carolina
city: Durham
country: United States
facility: Regeneron Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Regeneron Investigational Site
state: Ohio
city: Dublin
country: United States
facility: Regeneron Investigational Site
state: Ohio
city: Portland
country: United States
facility: Regeneron Investigational Site
state: Oregon
city: Camp Hill
country: United States
facility: Regeneron Investigational Site
state: Pennsylvania
city: Huntingdon
country: United States
facility: Regeneron Investigational Site
state: Pennsylvania
city: Ladson
country: United States
facility: Regeneron Investigational Site
state: South Carolina
city: Rapid City
country: United States
facility: Regeneron Investigational Site
state: South Dakota
city: Germantown
country: United States
facility: Regeneron Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: Regeneron Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Regeneron Investigational Site
state: Tennessee
city: Abilene
country: United States
facility: Regeneron Investigational Site
state: Texas
city: Austin
country: United States
facility: Regeneron Investigational Site 1
state: Texas
city: Austin
country: United States
facility: Regeneron Investigational Site 2
state: Texas
city: Dallas
country: United States
facility: Regeneron Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Regeneron Investigational Site 1
state: Texas
city: Fort Worth
country: United States
facility: Regeneron Investigational Site 2
state: Texas
city: Harlingen
country: United States
facility: Regeneron Investigational Site
state: Texas
city: Houston
country: United States
facility: Regeneron Investigational Site
state: Texas
city: The Woodlands
country: United States
facility: Regeneron Investigational Site
state: Texas
city: Willow Park
country: United States
facility: Regeneron Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Regeneron Investigational Site
state: Utah
city: Madison
country: United States
facility: Regeneron Investigational Site
state: Wisconsin
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: