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Clinical Trials in the USA / NCT07614776
Recruiting Phase 3

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

NCT07614776 · tracked via the Priya Life Science USA tracker
Sponsor
Amgen
Phase
Phase 3
Started
2026-05-27
Last updated
2026-09-17

Condition(s) studied

Neovascular Age-related Macular DegenerationnAMD

Investigational drug(s) / intervention(s)

ABP 938 8 mgAflibercept (US) 8 mg

ABP 938 8 mg: IVT injection

Aflibercept (US) 8 mg: IVT injection

Study 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

Sex
ALL
Min age
50 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (64)

FacilityCityRegionStatus
Retina Consultants of Orange County Fullerton California Recruiting
South Coast Retina Center - RCA Long Beach California Recruiting
Retinal Consultants Medical Group, Inc.-Sacramento, Greenback Lane, (RCA) Modesto California Recruiting
California Eye Specialists Medical Group, Inc Pasadena California Recruiting
Retinal Consultants Medical Group, Inc - Sacramento - Parkcenter Drive (RCA) Sacramento California Recruiting
California Retina Consultants Santa Barbara California Recruiting
Retina Consultants of Southern Colorado (Colorado Springs)- RCA Colorado Springs Colorado Recruiting
Retina Consultants of Southern Colorado (Pueblo)- RCA Colorado Springs Colorado Recruiting
Colorado Retina Associates (RCA) Lakewood Colorado Recruiting
Retina Group of New England Waterford Connecticut Recruiting
Medeye Associates - Research Miami Florida Recruiting
Retina Consultants of Southwest Florida - Naples Naples Florida Recruiting
Advanced Research, LLC Pensacola Florida Recruiting
Retina Associates Elmhurst Illinois Recruiting
University Retina - Bedford Park Location Oak Forest Illinois Recruiting
Associated Vitreoretinal and Uveitis Consultants Carmel Indiana Recruiting
The Retina Care Center- Baltimore (PRISM Vision Group) Baltimore Maryland Recruiting
Mid Atlantic Retina Specialists Hagerstown Maryland Recruiting
Retina Specialists Towson Maryland Recruiting
Ophthalmic Consultants of Boston Boston Massachusetts Recruiting
Retina Consultants of Minnesota Edina Minnesota Recruiting
Mississippi Retina Assoc Madison Mississippi Recruiting
The Retina Institute, Research Retina Institute (RCA) St Louis Missouri Recruiting
Envision Ocular, LLC Bloomfield New Jersey Recruiting
Vision Research Center Eye Associates of New Mexico Albuquerque New Mexico Recruiting
Retina Vitreous Surgeons of CNY, PC Liverpool New York Recruiting
Ophthalmic Consultants of Long Island - Research Oceanside New York Recruiting
North Carolina Retina Associates Raleigh North Carolina Recruiting
NC Retina Associates-RCA Wake Forest North Carolina Recruiting
Midwest Retina - Main Office Dublin Ohio Recruiting
Eye Care Specialists - Kingston Kingston Pennsylvania Recruiting
Retina Consultants of South Carolina, Charleston Neuroscience institute - Blufffon (RCA) Beaufort South Carolina Recruiting
Charleston Neuroscience Institute Charleston South Carolina Recruiting
Palmetto Retina Center - Main (RCA) Columbia South Carolina Recruiting
Retina Consultants of South Carolina, Charleston Neuroscience Institute- Ladson (RCA) Ladson South Carolina Recruiting
Retina Consultants of South Carolina, Charleston Neuroscience Institute- Mount Pleasant (RCA) Mt. Pleasant South Carolina Recruiting
Palmetto Retina Center, Florence (RCA) West Columbia South Carolina Recruiting
Tennessee Retina PC Nashville Tennessee Recruiting
Texas Retina Associates (TRA) - Arlington Arlington Texas Recruiting
Austin Retina Associates - Ophthalmology/Retina Austin Texas Recruiting

+ 24 more sites — see the full list on the official registry below.

More Amgen trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07614776 on ClinicalTrials.gov ↗ ← All trials in the USA