Clinical trial NCT02418754: Study of Intravitreal REGN2176-3 in Participants With Neovascular ("Wet") Age-Related Macular Degeneration (AMD)
Official title: A Phase 2, Double-Masked, Randomized, Controlled, Multiple-Dose, Regimen-Ranging Study of the Efficacy and Safety of Intravitreal REGN2176-3 in Patients With Neovascular Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Neovascular Age-Related Macular Degeneration
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-04-16
Enrollment: 505
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 was to explore the effect of REGN2176-3 on the Early Treatment Diabetic Retinopathy Scale (ETDRS) best-corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (AMD), compared to intravitreal aflibercept injection (IAI) monotherapy.

The secondary objectives of the study were the following:

* To explore the effect of 2 dose levels of IVT REGN2176-3 on anatomical changes of CNV in participants with nAMD compared to IAI monotherapy (at week 12)
* To evaluate if short-term treatment with REGN2176-3 followed by IAI monotherapy offered the same or additional benefit compared to continuous treatment with REGN2176-3. Also to determine if there was benefit in initiating IAI treatment prior to REGN2176-3 compared to continuous treatment with IAI.
* To assess the safety and tolerability of IVT REGN2176-3 in participants with nAMD


Eligibility criteria: Key Inclusion Criteria:

1. Men or women ≥50 years of age
2. Active subfoveal CNV secondary to AMD as evidenced by FA in the study eye, as determined by the reading center, including juxtafoveal lesions that affect the fovea
3. BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye at the screening visit
4. Provide signed informed consent

Key Exclusion Criteria:

1. Any prior treatment with anti-VEGF treatment in the study eye
2. Any prior treatment (ie, systemic or ocular treatment) with PDGF or PDGFR inhibitors
3. Dense fibrotic scar or atrophy in the study eye involving the center of the fovea
4. Presence of retinal pigment epithelial tears or rips involving the macula in the study eye
5. Prior vitrectomy in the study eye
6. Any history of macular hole of stage 2 and above in the study eye
7. Any intraocular or periocular surgery within 3 months of day 1 in the study eye, except lid surgery
8. History of corneal transplant in the study eye
9. Evidence of diabetic retinopathy or diabetic macular edema in either eye
10. Positive serum human chorionic gonadotropin/urine pregnancy test at the screening or baseline visit

Primary outcomes:
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Central Subfield Retinal Thickness (CST) at Week 12, as Measured by Optical Coherence Tomography (OCT)
timeFrame: Baseline, Week 12
measure: Percentage of Participants With Complete Resolution of Intraretinal and Subretinal Fluid From Baseline at Week 12 Measured by Optical Coherence Tomography (OCT)
timeFrame: Week 12
measure: Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 12 Measured by Fluorescein Angiography (FA)
timeFrame: Baseline, Week 12
measure: Change From Baseline in Total Lesion Size at Week 12 Measured by Fluorescein Angiography (FA)
timeFrame: Baseline, Week 12
measure: Percentage of Participants Who Gained At Least 15 Letters in BCVA From Baseline at Week 12, Measured by 4-meter Early Treatment Diabetic Retinopathy Scale (ETDRS)
timeFrame: Week 12
measure: Percent Change From Baseline in Subretinal Hyperreflectivity Material (SHM) at Week 12 Measured by Optical Coherence Tomography (OCT)
timeFrame: Baseline, Week 12
measure: Change From Baseline in Central Retinal/Lesion Thickness at Week 12 Measured by Optical Coherence Tomography (OCT)
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Phoenix
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: Irvine
country: United States
state: California
city: Mountain View
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Fort Lauderdale
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Plantation
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: Marietta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Oak Forest
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Urbana
country: United States
state: Illinois
city: Iowa City
country: United States
state: Iowa
city: Shawnee Mission
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Paducah
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Towson
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Jackson
country: United States
state: Michigan
city: Southfield
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Florissant
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Bloomfield
country: United States
state: New Jersey
city: New Brunswick
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Albany
country: United States
state: New York
city: East Setauket
country: United States
state: New York
city: Great Neck
country: United States
state: New York
city: New York
country: United States
state: New York
city: Orchard Park
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: Cincinnati
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Kingston
country: United States
state: Pennsylvania
city: Monroeville
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Florence
country: United States
state: South Carolina
city: Ladson
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: Knoxville
country: United States
state: Tennessee
city: Memphis
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: Houston
country: United States
state: Texas
city: McAllen
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: Salt Lake City
country: United States
state: Utah
city: Burlington
country: United States
state: Vermont
city: Fairfax
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
city: Akita
country: Japan
city: Asahikawa
country: Japan
city: Chiyoda-ku
country: Japan
city: Fukushima
country: Japan
city: Kawasaki
country: Japan
city: Matsumoto
country: Japan
city: Nagasaki
country: Japan
city: Nagoya
country: Japan
city: Osaka
country: Japan
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: