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Neovascular Age-related Macular DegenerationPhase 3NCT07614776

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

A Phase 3 study testing ABP 938 8 mg and Aflibercept (US) 8 mg in people with Neovascular Age-related Macular Degeneration and nAMD, run by Amgen at 81 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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) Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
ABP 938 8 mg and Aflibercept (US) 8 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
304 participants
Where
81 sitesin 9 countries
Study dates
27 May 2026to 12 Jan 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

81 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Amgen Call Center contact

866-572-6436

medinfo@amgen.com

81 sites in 9 countries

United States55 sites, 55 recruiting

  • Vision Research Center Eye Associates of New Mexico

    Albuquerque, New Mexico, 87109

    Recruiting

  • Texas Retina Associates (TRA) - Arlington

    Arlington, Texas, 76012

    Recruiting

  • Austin Retina Associates - Ophthalmology/Retina

    Austin, Texas, 78705

    Recruiting

  • Austin Retina Associates

    Austin, Texas, 78705

    Recruiting

  • The Retina Care Center- Baltimore (PRISM Vision Group)

    Baltimore, Maryland, 21209

    Recruiting

  • Retina Consultants of South Carolina, Charleston Neuroscience institute - Blufffon (RCA)

    Beaufort, South Carolina, 29902

    Recruiting

  • Retina Consultants of Texas - Bellaire

    Bellaire, Texas, 77401

    Recruiting

  • Vitreoretinal Associates of Washington

    Bellevue, Washington, 98004-3779

    Recruiting

  • Envision Ocular, LLC

    Bloomfield, New Jersey, 07003

    Recruiting

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114

    Recruiting

  • Associated Vitreoretinal and Uveitis Consultants

    Carmel, Indiana, 46032

    Recruiting

  • Charleston Neuroscience Institute

    Charleston, South Carolina, 29414-5896

    Recruiting

  • University Retina - Bedford Park Location

    Chicago, Illinois, 60452

    Recruiting

  • Retina Consultants of Southern Colorado (Colorado Springs)- RCA

    Colorado Springs, Colorado, 80909-1183

    Recruiting

  • Retina Consultants of Southern Colorado (Pueblo)- RCA

    Colorado Springs, Colorado, 80909

    Recruiting

  • Palmetto Retina Center - Main (RCA)

    Columbia, South Carolina, 29169

    Recruiting

  • Texas Retina Associates (TRA) - Dallas Main

    Dallas, Texas, 75231

    Recruiting

  • Midwest Retina - Main Office

    Dublin, Ohio, 43016

    Recruiting

  • Retina Consultants of Minnesota (RCM) - St. Louis Park

    Edina, Minnesota, 55435

    Recruiting

  • Retina Associates

    Elmhurst, Illinois, 60126

    Recruiting

  • Emerson Clinical Research- Virginia Retina Specialists

    Falls Church, Virginia, 22042-2349

    Recruiting

  • Texas Retina Associates - Fort Worth

    Fort Worth, Texas, 76104

    Recruiting

  • Retina Consultants of Orange County

    Fullerton, California, 92835-3432

    Recruiting

  • Mid Atlantic Retina Specialists

    Hagerstown, Maryland, 21740-5846

    Recruiting

  • Retina Consultants of Texas - Katy Retina Center

    Houston, Texas, 77401

    Recruiting

  • Retina Consultants of Texas - The Woodlands

    Katy, Texas, 77494

    Recruiting

  • Eye Care Specialists - Kingston

    Kingston, Pennsylvania, 18704-4801

    Recruiting

  • Retina Consultants of South Carolina, Charleston Neuroscience Institute- Ladson (RCA)

    Ladson, South Carolina, 29456

    Recruiting

  • Colorado Retina Associates (RCA)

    Lakewood, Colorado, 80228

    Recruiting

  • Retina Vitreous Surgeons of CNY, PC

    Liverpool, New York, 13088

    Recruiting

  • South Coast Retina Center - RCA

    Long Beach, California, 90607

    Recruiting

  • Mississippi Retina Assoc

    Madison, Mississippi, 39110

    Recruiting

  • Medeye Associates - Research

    Miami, Florida, 33143

    Recruiting

  • Retinal Consultants Medical Group, Inc - Modesto (RCA)

    Modesto, California, 95356

    Recruiting

  • Retina Consultants of South Carolina, Charleston Neuroscience Institute- Mount Pleasant (RCA)

    Mt. Pleasant, South Carolina, 29464

    Recruiting

  • Retina Consultants of Southwest Florida - Naples

    Naples, Florida, 34103-4457

    Recruiting

  • Tennessee Retina PC

    Nashville, Tennessee, 37203

    Recruiting

  • Ophthalmic Consultants of Long Island - Research

    Oceanside, New York, 11572

    Recruiting

  • California Eye Specialists Medical Group, Inc

    Pasadena, California, 91107

    Recruiting

  • Advanced Research, LLC

    Pensacola, Florida, 32503

    Recruiting

  • North Carolina Retina Associates

    Raleigh, North Carolina, 27607-7514

    Recruiting

  • Retinal Consultants Medical Group, Inc - Sacramento - Parkcenter Drive (RCA)

    Sacramento, California, 95825

    Recruiting

  • Retina Associates of Utah - Retina Specialist

    Salt Lake City, Utah, 84107

    Recruiting

  • Retinal Consultants of Texas- San Antonio

    San Antonio, Texas, 78240

    Recruiting

  • California Retina Consultants

    Santa Barbara, California, 93103

    Recruiting

  • Long Island Vitreoretinal Consultants(RCA Network)

    Scarsdale, New York, 10583-5032

    Recruiting

  • Retina Consultants of Texas - Schertz

    Schertz, Texas, 78154

    Recruiting

  • Retina Center NW PLLC

    Silverdale, Washington, 98383

    Recruiting

  • Spokane Eye Clinic (OCT and optical exam

    Spokane, Washington, 99204-2509

    Recruiting

  • The Retina Institute, Research Retina Institute (RCA)

    St Louis, Missouri, 63128

    Recruiting

  • Retina Specialists

    Towson, Maryland, 21204

    Recruiting

  • NC Retina Associates- RCA

    Wake Forest, North Carolina, 27587

    Recruiting

  • Retina Group of New England

    Waterford, Connecticut, 06385

    Recruiting

  • Palmetto Retina Center, Florence (RCA)

    West Columbia, South Carolina, 29169

    Recruiting

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087

    Recruiting

Other trials in United States

Czechia5 sites, 5 recruiting

  • Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje - Klaudianova nemocnice

    Mladá Boleslav, Stredoceský Kraj, 293 01

    Recruiting

  • Visus, spol. s r.o. - Nachod

    Náchod, Hradec Králové Region, 547 01

    Recruiting

  • Fakultni nemocnice Ostrava - Ocni klinika

    Ostrava - Poruba, Ostrava-město, 708 52

    Recruiting

  • AXON clinical

    Prague, Prague, 150 00

    Recruiting

  • FN Kralovske Vinohrady - Oftalmologicka klinika

    Prague, 100 34

    Recruiting

Other trials in Czechia

Slovakia5 sites, 5 recruiting

  • FNsP F.D.R. Banska Bystrica - II. Ocna klinika SZU

    Banska Bystrica, Trenčín Region, 975 17

    Recruiting

  • Univerzitna nemocnica Bratislava - Ocna klinika SZU a UNB

    Bratislava, Bratislava Region, 851 07

    Recruiting

  • NsP Trebisov, a.s. - Ocne oddelenie

    Trebišov, Košice Region, 075 01

    Recruiting

  • Fakultna nemocnica Trencin - Ocna klinika

    Trenčín, Trenčín Region, 911 71

    Recruiting

  • Fakultna nemocnica s poliklinikou Zilina - Ocne oddelenie

    Žilina, Žilina Region, 012 07

    Recruiting

Other trials in Slovakia

Japan4 sites, 4 recruiting

  • Tokyo Medical Center - Ophthalmology

    Meguro-ku, Tokyo, 152-8902

    Recruiting

  • SUGITA EYE HOSPITAL - Ophthalmology

    Nagoya, Aichi-ken, 460-0008

    Recruiting

  • Nihon University Hospital - Ophthalmology

    Tokyo, 101-8309

    Recruiting

  • Tokushima University Hospital - Ophthalmology

    Ube, Yamaguchi, 7558505

    Recruiting

Other trials in Japan

Spain4 sites, 4 recruiting

  • Centro de Oftalmologia Barraquer (Barraquer Ophthalmology Centre)

    Barcelona, Catalonia, 8021

    Recruiting

  • Clinica Universidad de Navarra - Oftalmología

    Navarra, Navarre, 31008

    Recruiting

  • Hospital Universitari General de Catalunya

    San Cugat Del Valles, Barcelona, 08190

    Recruiting

  • Hospital Provincial De Conxo - Oftalmología

    Santiago de Compostela, Sevilla, 15706

    Recruiting

Other trials in Spain

Poland3 sites, 3 recruiting

  • OFTALMIKA Sp. z o. o.

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-631

    Recruiting

  • Szpital sw. Rozy Sp. z o.o.

    Krakow, Masovian Voivodeship, 30-363

    Recruiting

  • Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.

    Olsztyn, Warmian-Masurian Voivodeship, 10-424

    Recruiting

Other trials in Poland

Hungary2 sites, 2 recruiting

  • Eszak-pesti Centrumkorhaz - Honvedkorhaz

    Budapest, H-1062

    Recruiting

  • Debreceni Egyetem OEC - Ophthalmology

    Debrecen, Hajdú-Bihar, 4032

    Recruiting

Other trials in Hungary

Latvia2 sites, 2 recruiting

  • Latvian American Eye Center

    Riga, Riga, LV-1009

    Recruiting

  • P.Stradina Clinical University Hospital - Ophthalmology

    Riga, 1002

    Recruiting

Other trials in Latvia

Lithuania1 site, 1 recruiting

  • Lietuvos Sveikatos Mokslu Universitetas (LSMU) - Kauno Klinikos - ophthalmology

    Kaunas, Kaunas County, 50009

    Recruiting

Other trials in Lithuania

About this study

Official title: 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

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)

Being tested
ABP 938 8 mg, Aflibercept (US) 8 mg
Keywords
ABP 938, Aflibercept, neovascular age-related macular degeneration, Intravitreal, Randomized Controlled Trial, Double-masked

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABP 938 8 mgDrug

    IVT injection

  • Aflibercept (US) 8 mgDrug

    Also called EYLEA HD

    IVT injection

Study groups in NCT07614776
Study groupRoleWhat they receive
ABP 938 8 mgExperimentalParticipants 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.
Receives: Drug: ABP 938 8 mg
Aflibercept (US) 8 mgActive comparatorParticipants 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.
Receives: Drug: Aflibercept (US) 8 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score

    Measured: Baseline and Week 12

Secondary outcomes (17)

  1. Percentage of Participants With Absence of Intraretinal Fluid (IRF) and Subretinal Fluid (SRF) in the Center Subfield, as Assessed by Spectral-Domain Optical Coherence Tomography (SD-OCT)

    Measured: Week 16

  2. Change from Baseline in BCVA as measured by ETDRS letter score

    Measured: Baseline to Week 48

  3. Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 24

    Measured: Baseline to Week 24

  4. Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 48

    Measured: Baseline to Week 48

  5. Change From Baseline in Choroidal Neovascularization (CNV) Area Size as Measured by Fluorescein Angiography (FA)

    Measured: Baseline to Week 48

  6. Change From Baseline in Central Subfield Thickness (CST) as Measured by SD-OCT

    Measured: Baseline to Week 48

  7. Percentage of Participants Who Met Protocol-Defined DRA Criteria, as Determined by Protocol-Specified Clinical and Imaging Assessments

    Measured: Week 16 and Week 20

  8. Percentage of Participants Who Met Protocol-Defined DRA Criteria, as Determined by Protocol-Specified Clinical and Imaging Assessments

    Measured: Week 48

  9. Number of Participants Who Experienced Ocular Treatment-Emergent Adverse Events (TEAEs)

    Measured: Baseline up to Week 48

  10. Number of Participants Who Experienced Non-Ocular TEAEs

    Measured: Baseline up to Week 48

  11. Number of Participants Who Experienced Treatment-Emergent Events of Interest (EOI)

    Measured: Baseline up to Week 48

  12. Number of Participants Who Experienced Treatment-Emergent Serious Adverse Events (TESAEs)

    Measured: Baseline up to Week 48

  13. Number of Participants Who Developed Binding Antidrug Antibodies (ADAs)

    Measured: Baseline up to Week 48

  14. Free serum concentrations of ABP 938 8 mg

    Measured: Week 16, week 24 and 48 (End of Study)

  15. Free serum concentrations of Aflibercept (US) 8 mg

    Measured: Week 16, week 24, and 48 (End of Study)

  16. Pharmacokinetic (PK) parameters of ABP 938 8mg derived from concentration - time profiles following the first dose in a PK substudy

    Measured: From Baseline (day 1, week 0) to Day 29 (pre dose week 4)

  17. Pharmacokinetic parameters of Aflibercept (US) 8 mg derived from concentration - time profiles following the first dose in a PK substudy

    Measured: From Baseline (day 1, week 0) to Day 29 (pre dose week 4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2026
  2. Study start27 May 2026
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion12 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
304 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07614776
Sponsor's protocol ID
20250115
Other IDs
2025-523500-72-00, 2025
Status last verified
Oct 2026
First submitted
22 May 2026
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ABP 938 8 mg and Aflibercept (US) 8 mg in people with Neovascular Age-related Macular Degeneration and nAMD, run by Amgen at 81 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in United States, Czechia, Slovakia, Japan, Spain and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07614776.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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