Clinical trial NCT04126317: Safety, Tolerability, and Efficacy of Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
Official title: A Randomized, Single-Masked, Active-Controlled Phase 2 Study of the Safety, Tolerability, and Efficacy of Repeated Doses of High-Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neovascular (Wet) Age-Related Macular Degeneration
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2019-10-15
Enrollment: 106
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 objectives of the study are to determine the safety of high-dose aflibercept (hereafter referred to as HD) and to determine if HD provides greater intraocular pharmacodynamic (PD) effect and/or longer duration of action compared to intravitreal aflibercept injection (hereafter referred to as IAI).


Eligibility criteria: Key Inclusion Criteria:

* Men or women ≥50 years of age with active subfoveal choroidal neovascularization (CNV) secondary to nAMD
* Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 78 to 24 (Snellen equivalent of 20/32 to 20/320) in the study eye

Key Exclusion Criteria:

* Evidence of CNV due to any cause other than nAMD in either eye
* Evidence of diabetic macular edema (DME) or diabetic retinopathy (defined as more than 1 microaneurysm) in either eye in diabetic patients
* Prior use of IVT anti-VEGF agents (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) in the study eye
* Prior IVT investigational agents in either eye (eg, anti-ang-2/anti-VEGF bispecific monoclonal antibodies, gene therapy)
* Previous use of intraocular or periocular corticosteroids within 120 days of screening or treatment with an IVT steroid implant at any time in the study eye
* History of vitreoretinal surgery (including scleral buckling) in the study eye
* Any other intraocular surgery within 12 weeks (84 days) before the screening visit
* History of corneal transplant or corneal dystrophy in study eye

NOTE: Other protocol defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
timeFrame: Up to Week 44
measure: Number of Participants With at Least One Serious TEAE
timeFrame: Up to Week 44
measure: Number of Participants Without Retinal Fluid in the Center Subfield of Study Eye
timeFrame: At Week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Regeneron Study Site
state: Arizona
city: Sun City
country: United States
facility: Regeneron Study Site
state: Arizona
city: Encino
country: United States
facility: Regeneron Study Site
state: California
city: Fullerton
country: United States
facility: Regeneron Study Site
state: California
city: Mountain View
country: United States
facility: Regeneron Study Site
state: California
city: Palm Desert
country: United States
facility: Regeneron Study Site
state: California
city: Sacramento
country: United States
facility: Regeneron Study Site
state: California
city: Santa Ana
country: United States
facility: Regeneron Study Site
state: California
city: Colorado Springs
country: United States
facility: Regeneron Study Site
state: Colorado
city: Golden
country: United States
facility: Regeneron Study Site
state: Colorado
city: Waterford
country: United States
facility: Regeneron Study Site
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Regeneron Study Site
state: Florida
city: Fort Myers
country: United States
facility: Regeneron Study Site
state: Florida
city: Lakeland
country: United States
facility: Regeneron Study Site
state: Florida
city: Largo
country: United States
facility: Regeneron Study Site
state: Florida
city: Melbourne
country: United States
facility: Regeneron Study Site
state: Florida
city: Tallahassee
country: United States
facility: Regeneron Study Site
state: Florida
city: Winter Haven
country: United States
facility: Regeneron Study Site
state: Florida
city: Augusta
country: United States
facility: Regeneron Study Site
state: Georgia
city: Marietta
country: United States
facility: Regeneron Study Site
state: Georgia
city: Oak Forest
country: United States
facility: Regeneron Study Site
state: Illinois
city: Hagerstown
country: United States
facility: Regeneron Study Site
state: Maryland
city: Royal Oak
country: United States
facility: Regeneron Study Site
state: Michigan
city: Bloomfield
country: United States
facility: Regeneron Study Site
state: New Jersey
city: Teaneck
country: United States
facility: Regeneron Study Site
state: New Jersey
city: Albuquerque
country: United States
facility: Regeneron Study Site
state: New Mexico
city: Great Neck
country: United States
facility: Regeneron Study Site
state: New York
city: Asheville
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Charlotte
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Columbus
country: United States
facility: Regeneron Study Site
state: Ohio
city: Edmond
country: United States
facility: Regeneron Study Site
state: Oklahoma
city: Portland
country: United States
facility: Regeneron Study Site
state: Oregon
city: Kingston
country: United States
facility: Regeneron Study Site
state: Pennsylvania
city: Ladson
country: United States
facility: Regeneron Study Site
state: South Carolina
city: West Columbia
country: United States
facility: Regeneron Study Site
state: South Carolina
city: Rapid City
country: United States
facility: Regeneron Study Site
state: South Dakota
city: Abilene
country: United States
facility: Regeneron Study Site
state: Texas
city: Arlington
country: United States
facility: Regeneron Study Site
state: Texas
city: Austin
country: United States
facility: Regeneron Study Site
state: Texas
city: Houston
country: United States
facility: Regeneron Study Site
state: Texas
city: The Woodlands
country: United States
facility: Regeneron Study Site
state: Texas
city: Salt Lake City
country: United States
facility: Regeneron Study Site
state: Utah
city: Fairfax
country: United States
facility: Regeneron Study Site
state: Virginia
city: Spokane
country: United States
facility: Regeneron Study Site
state: Washington
city: Morgantown
country: United States
facility: Regeneron Study Site
state: West Virginia
city: Arecibo
country: Puerto Rico
facility: Regeneron Study Site
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: