A Randomized, Double-masked, Comparative Clinical Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 938 8 mg Versus EYLEA® HD (Aflibercept) Delivered Via Intravitreal Injection in Participants With Neovascular Age-related Macular Degeneration
Status: Recruiting
Location: See all (58) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The aim of this trial is to demonstrate similarity in efficacy between ABP 938 8 mg and aflibercept (US) 8 mg by evaluating the change in best corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (nAMD)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:
• Men or women ≥ 50 years old, capable of giving signed informed consent
• Active, treatment-naïve subfoveal CNV lesions secondary to nAMD including juxtafoveal lesions that affect the fovea as confirmed by SD-OCT and FA in the study eye (SE)
• Total area of CNV (including both classic and occult components) \> 50% of the total lesion area in the SE
• The BCVA letter score ≥ 24 and ≤ 78 letters, in the SE
• Presence of intra and/or subretinal fluid affecting the central subfield of the SE as identified by SD-OCT attributable to active CNV. The central subfield is defined as a circle with a diameter of 1 mm, centered on the fovea
Locations
United States
California
Retina Consultants of Orange County
RECRUITING
Fullerton
South Coast Retina Center - RCA
RECRUITING
Long Beach
Retinal Consultants Medical Group, Inc.-Sacramento, Greenback Lane, (RCA)
RECRUITING
Modesto
California Eye Specialists Medical Group, Inc
RECRUITING
Pasadena
Retinal Consultants Medical Group, Inc - Sacramento - Parkcenter Drive (RCA)
RECRUITING
Sacramento
California Retina Consultants
RECRUITING
Santa Barbara
Colorado
Retina Consultants of Southern Colorado (Colorado Springs)- RCA
RECRUITING
Colorado Springs
Retina Consultants of Southern Colorado (Pueblo)- RCA
RECRUITING
Colorado Springs
Colorado Retina Associates (RCA)
RECRUITING
Lakewood
Connecticut
Retina Group of New England
RECRUITING
Waterford
Florida
Medeye Associates - Research
RECRUITING
Miami
Retina Consultants of Southwest Florida - Naples
RECRUITING
Naples
Advanced Research, LLC
RECRUITING
Pensacola
Illinois
Retina Associates
RECRUITING
Elmhurst
University Retina - Bedford Park Location
RECRUITING
Oak Forest
Indiana
Associated Vitreoretinal and Uveitis Consultants
RECRUITING
Carmel
Massachusetts
Ophthalmic Consultants of Boston
RECRUITING
Boston
Maryland
The Retina Care Center- Baltimore (PRISM Vision Group)
RECRUITING
Baltimore
Mid Atlantic Retina Specialists
RECRUITING
Hagerstown
Retina Specialists
RECRUITING
Towson
Minnesota
Retina Consultants of Minnesota
RECRUITING
Edina
Missouri
The Retina Institute, Research Retina Institute (RCA)
RECRUITING
St Louis
Mississippi
Mississippi Retina Assoc
RECRUITING
Madison
North Carolina
North Carolina Retina Associates
RECRUITING
Raleigh
NC Retina Associates-RCA
RECRUITING
Wake Forest
New Jersey
Envision Ocular, LLC
RECRUITING
Bloomfield
New Mexico
Vision Research Center Eye Associates of New Mexico
RECRUITING
Albuquerque
New York
Retina Vitreous Surgeons of CNY, PC
RECRUITING
Liverpool
Ophthalmic Consultants of Long Island - Research
RECRUITING
Oceanside
Ohio
Midwest Retina - Main Office
RECRUITING
Dublin
Pennsylvania
Eye Care Specialists - Kingston
RECRUITING
Kingston
South Carolina
Retina Consultants of South Carolina, Charleston Neuroscience institute - Blufffon (RCA)
RECRUITING
Beaufort
Charleston Neuroscience Institute
RECRUITING
Charleston
Palmetto Retina Center - Main (RCA)
RECRUITING
Columbia
Retina Consultants of South Carolina, Charleston Neuroscience Institute- Ladson (RCA)
RECRUITING
Ladson
Retina Consultants of South Carolina, Charleston Neuroscience Institute- Mount Pleasant (RCA)
RECRUITING
Mt. Pleasant
Palmetto Retina Center, Florence (RCA)
RECRUITING
West Columbia
Tennessee
Tennessee Retina PC
RECRUITING
Nashville
Texas
Texas Retina Associates (TRA) - Arlington
RECRUITING
Arlington
Austin Retina Associates
RECRUITING
Austin
Austin Retina Associates - Ophthalmology/Retina
RECRUITING
Austin
Retina Consultants of Texas - Bellaire
RECRUITING
Bellaire
Texas Retina Associates (TRA) - Dallas Main
RECRUITING
Dallas
Texas Retina Associates - Fort Worth
RECRUITING
Fort Worth
Retina Consultants of Texas - Katy Retina Center
RECRUITING
Houston
Retina Consultants of Texas - The Woodlands
RECRUITING
Katy
Retinal Consultants of Texas- San Antonio
RECRUITING
San Antonio
Retina Consultants of Texas - Schertz
RECRUITING
Schertz
Strategic Clinical Research Group, LLC
RECRUITING
Willow Park
Utah
Retina Associates of Utah - Retina Specialist
RECRUITING
Salt Lake City
Virginia
Emerson Clinical Research- Virginia Retina Specialists
RECRUITING
Falls Church
Washington
Vitreoretinal Associates of Washington
RECRUITING
Bellevue
Retina Center NW PLLC
RECRUITING
Silverdale
Spokane Eye Clinic (OCT and optical exam
RECRUITING
Spokane
Other Locations
Latvia
Latvian American Eye Center
RECRUITING
Riga
Poland
Szpital sw. Rozy Sp. z o.o.
RECRUITING
Kraków
Slovakia
NsP Trebisov, a.s. - Ocne oddelenie
RECRUITING
Trebišov
Fakultna nemocnica Trencin - Ocna klinika
RECRUITING
Trenčín
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2026-05-27
Estimated Completion Date: 2028-01-12
Participants
Target number of participants: 304
Treatments
Experimental: ABP 938 8 mg
Participants will receive intravitreal ABP 938 8 mg injections at Baseline, Week 4, and Week 8. Participants will then be assessed at scheduled study visits, with Dose Regimen Adjustment (DRA) decisions beginning at Week 16 based on predefined disease-activity criteria. Injections will be administered at protocol-defined intervals ranging from every 4 to 16 weeks through the end of the study.
Active_comparator: Aflibercept (US) 8 mg
Participants will receive intravitreal Aflibercept (US) 8 mg injections at Baseline, Week 4, and Week 8. Participants will then be assessed at scheduled study visits, with DRA decisions beginning at Week 16 based on predefined disease-activity criteria. Injections will be administered at protocol-defined intervals ranging from every 4 to 16 weeks through the end of the study.
Related Therapeutic Areas
Sponsors
Leads: Amgen