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A Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA® HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration

RecruitingPhase 3

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

Who can join

Ages 50 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply at either screening or baseline, unless otherwise indicated per protocol:

* Total lesion size \> 12 disc areas (30.5 mm2) including blood, scars, and neovascularization, in the study eye
* Scar, fibrosis, or atrophy involving the central subfield in the study eye
* Scar or fibrosis involving \> 50% of the total lesion in the study eye
* Presence of retinal pigment epithelium tears or rips involving the macula in the study eye
* History of any vitreous hemorrhage ≤ 4 weeks (28 days) before randomization in the study
* Presence of other causes of CNV, including pathologic myopia (spherical equivalent ≥ 8 diopters negative or axial length ≥ 25 mm), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study
* Uncontrolled glaucoma (defined as IOP \>25 mmHg despite treatment with anti-glaucoma medication) in the study eye
* History or clinical evidence of DR, DME, idiopathic autoimmune uveitis, or any other vascular disease affecting the retina, other than nAMD in either eye
* Evidence of active extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening or randomization
* Uncontrolled blood pressure (defined as systolic \>160 mmHg or diastolic \>95 mmHg). Blood pressure needs to be stable for at least 12 weeks (84 days) prior to screening
* Any prior or concomitant ocular or systemic treatment (with an investigational or approved, anti VEGF or anti-VEGF/anti-angiopoietin agent) in the SE, or surgery for nAMD in the SE, except dietary supplements or vitamins
* History or evidence of any other clinically significant disorder, condition, disease or clinical laboratory abnormality that, in the opinion of the investigator or study medical monitor, if consulted, would pose a risk to participant safety or interfere with the study evaluation or results interpretation
* Other protocol-specified exclusion criteria

About the study

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)

What is being tested

Sponsor: Amgen · Participants: 304 · Started: May 27, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07614776

Locations in the U.S.

CaliforniaRetina Consultants of Orange County, Fullerton
South Coast Retina Center - RCA, Long Beach
Retinal Consultants Medical Group, Inc - Modesto (RCA), Modesto
California Eye Specialists Medical Group, Inc, Pasadena
Retinal Consultants Medical Group, Inc - Sacramento - Parkcenter Drive (RCA), Sacramento
California Retina Consultants, Santa Barbara
ColoradoRetina Consultants of Southern Colorado (Colorado Springs)- RCA, Colorado Springs
Retina Consultants of Southern Colorado (Pueblo)- RCA, Colorado Springs
Colorado Retina Associates (RCA), Lakewood
ConnecticutRetina Group of New England, Waterford
FloridaMedeye Associates - Research, Miami
Retina Consultants of Southwest Florida - Naples, Naples
Advanced Research, LLC, Pensacola
IllinoisUniversity Retina - Bedford Park Location, Chicago
Retina Associates, Elmhurst
IndianaAssociated Vitreoretinal and Uveitis Consultants, Carmel
MarylandThe Retina Care Center- Baltimore (PRISM Vision Group), Baltimore
Mid Atlantic Retina Specialists, Hagerstown
Retina Specialists, Towson
MassachusettsOphthalmic Consultants of Boston, Boston
MinnesotaRetina Consultants of Minnesota (RCM) - St. Louis Park, Edina
MississippiMississippi Retina Assoc, Madison
MissouriThe Retina Institute, Research Retina Institute (RCA), St Louis
New JerseyEnvision Ocular, LLC, Bloomfield
New MexicoVision Research Center Eye Associates of New Mexico, Albuquerque
New YorkRetina Vitreous Surgeons of CNY, PC, Liverpool
Ophthalmic Consultants of Long Island - Research, Oceanside
Long Island Vitreoretinal Consultants(RCA Network), Scarsdale
North CarolinaNorth Carolina Retina Associates, Raleigh
NC Retina Associates- RCA, Wake Forest
OhioMidwest Retina - Main Office, Dublin
PennsylvaniaEye Care Specialists - Kingston, Kingston
South CarolinaRetina Consultants of South Carolina, Charleston Neuroscience institute - Blufffon (RCA), Beaufort
Charleston Neuroscience Institute, Charleston
Palmetto Retina Center - Main (RCA), Columbia
Retina Consultants of South Carolina, Charleston Neuroscience Institute- Ladson (RCA), Ladson
Retina Consultants of South Carolina, Charleston Neuroscience Institute- Mount Pleasant (RCA), Mt. Pleasant
Palmetto Retina Center, Florence (RCA), West Columbia
TennesseeTennessee Retina PC, Nashville
TexasTexas Retina Associates (TRA) - Arlington, Arlington
Austin Retina Associates, Austin
Austin Retina Associates - Ophthalmology/Retina, Austin
Retina Consultants of Texas - Bellaire, Bellaire
Texas Retina Associates (TRA) - Dallas Main, Dallas
Texas Retina Associates - Fort Worth, Fort Worth
Retina Consultants of Texas - Katy Retina Center, Houston
Retina Consultants of Texas - The Woodlands, Katy
Retinal Consultants of Texas- San Antonio, San Antonio
Retina Consultants of Texas - Schertz, Schertz
Strategic Clinical Research Group, LLC, Willow Park
UtahRetina Associates of Utah - Retina Specialist, Salt Lake City
VirginiaEmerson Clinical Research- Virginia Retina Specialists, Falls Church
WashingtonVitreoretinal Associates of Washington, Bellevue
Retina Center NW PLLC, Silverdale
Spokane Eye Clinic (OCT and optical exam, Spokane

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.