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New biosimilar could offer cheaper Vision-Saving shots for wet AMD

NCT ID NCT04270747

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 3 trial tested whether a new drug called ABP 938 works as well as the standard treatment Eylea for wet age-related macular degeneration (AMD), a leading cause of vision loss. 576 adults aged 50 and older with wet AMD received injections of either ABP 938 or Eylea every 4 weeks for 3 doses, then every 8 weeks. The study measured changes in vision and safety over a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ABP 938 (a biosimilar to aflibercept)
What this could lead to
If successful, ABP 938 could offer a more affordable treatment option for wet AMD, helping to preserve vision with regular injections.
What could go wrong
This is a comparison study, not a new cure. ABP 938 may not be as effective or safe as Eylea, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

576 people

The number who actually took part.

Started

Jun 2020

Finished

Jan 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects or their legally authorized representative must sign an Institutional Review Board/Independent Ethics Committee approved informed consent form before any study-specific procedures * Men or women ≥ 50 years old * Subjects must be diagnosed with neovascular (wet) AMD in the study eye * Active treatment naïve subfoveal CNV lesions secondary to neovascular (wet) AMD including juxtafoveal lesions that affect the fovea as confirmed with SD OCT, FA and/or Fundus Photography (FP) in the study eye * BCVA between 73 and 34 letters, inclusive, in the study eye using ETDRS testing * Presence of intra and/or subretinal fluid as identified by SD-OCT attributable to active CNV in the study eye * Central retinal thickness of \> 270µm in the study eye as measured by the machine, calculated average thickness in the central 1 mm subfield (CST) by SD-OCT at screening Exclusion Criteria: Subjects are excluded if they meet any of the following criteria in the study eye: * Total lesion size \> 12 disc areas (30.5 mm\^2, including blood, scars, and neovascularization) in the study eye * Active CNV area (classic plus occult components) that is \< 50% of the total lesion area in the study eye * Scar, fibrosis, or atrophy involving the center of the fovea in the study eye * Presence of retinal pigment epithelium tears or rips involving the macula in the study eye * History of any vitreous hemorrhage within 4 weeks before randomization in the study eye * Presence of other causes of CNV, including pathologic myopia (spherical equivalent of 8 diopters or more negative or axial length of 25 mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study eye * Prior vitrectomy or laser surgery of the macula (including photodynamic therapy or focal laser photocoagulation) in the study eye * History of retinal detachment in the study eye * Any history of macular hole of stage 2 and above in the study eye * Any macular pathology that might limit vision i.e., Vitreomacular traction or significant epiretinal membrane in the study eye * Any intraocular or periocular surgery within 3 months before randomization on the study eye, except lid surgery, which may not have taken place within 4 weeks before randomization, as long as it is unlikely to interfere with the injection * Prior trabeculectomy or other filtration surgery in the study eye * Uncontrolled glaucoma (defined as intraocular pressure ≥ 25 mmHg despite treatment with antiglaucoma medication) in the study eye * Aphakia or pseudophakia with complete absence of posterior capsule (unless it occurred as a result of a yttrium aluminum garnet \[YAG\] posterior capsulotomy) in the study eye * Previous therapeutic radiation in the region of the study eye * History of corneal transplant or corneal dystrophy in the study eye * Significant media opacities, including cataract, which might interfere with visual acuity or assessment of safety, in the study eye * Any concurrent intraocular condition other than neovascular (wet) AMD in the study eye that, in the opinion of the investigator, requires planned medical or surgical intervention during the study or increases the risk to the subject beyond what is expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety Subjects are excluded if they meet any of the following criteria in either eye: * History or clinical evidence of uveitis, diabetic retinopathy, diabetic macular edema, or any other vascular disease affecting the retina, other than neovascular (wet) AMD * Active intraocular inflammation or active or suspected ocular or periocular infection, within 2 weeks before randomization * Active scleritis or episcleritis or presence of scleromalacia Other Medical Conditions • Active extraocular infection or history of extraocular infections as follows: A. any active infection for which systemic anti-infectives were used within 4 weeks before randomization B. recurrent or chronic infections or other active infection that, in the opinion of the investigator, might cause this study to be detrimental to the subject * Acute coronary event or stroke within 3 months before randomization * Uncontrolled, clinically significant systemic disease such as diabetes mellitus, hypertension, cardiovascular disease including moderate to severe heart failure (New York Heart Association class III/IV), renal disease, or liver disease * Malignancy within 5 years EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, OR in situ breast ductal carcinoma Washouts and Nonpermitted Treatments * Any prior ocular or systemic treatment, including another investigational product or surgery for neovascular (wet) AMD (including anti vascular endothelial growth factor \[VEGF\] therapy) in the study eye, except dietary supplements or vitamins * Any ocular or systemic treatment including another investigational product or surgery for neovascular (wet) AMD (including anti VEGF therapy) in the fellow eye, within 30 days before randomization, except dietary supplements or vitamins * Prior systemic anti-VEGF treatment as follows: * Investigational or approved anti-VEGF therapy systemically within 3 months before randomization * Aflibercept, ziv-aflibercept, or a biosimilar of aflibercept/ziv-aflibercept systemically at any time * Any IVT therapy, including adrenocorticotropic hormone, in the study or fellow eye, or intramuscular or intravenous corticosteroids within 4 weeks before randomization. The use of long-acting steroids, either systemically or intraocularly, in the 3 months before randomization * Currently receiving treatment with another investigational device or study drug, or less than 30 days or 5 half-lives (whichever is longer) since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded General * For women: pregnant or breast feeding, or planning to become pregnant while enrolled in the study and for 3 months after the last dose of investigational product * Sexually active subjects and their partners who are of childbearing potential (ie, neither surgically sterile nor postmenopausal) and not agreeing to use adequate contraception (eg, true abstinence, sterilization, birth control pills, Depo Provera injections, contraceptive implants, or other effective methods) while on study and for 3 months after the last dose of study drug. Male subjects must agree not to donate sperm during study and for 3 months following treatment with test article or until the scheduled end of the study (whichever is longer) * Allergy or hypersensitivity to investigational product, to any of the excipients of ABP 938 or aflibercept, or to other study-related procedures/medications (eg, anesthesia, antiseptic, fluorescein dye) * History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion * Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the subject and investigator's knowledge

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Conditions

The condition(s) this trial relates to.

macular degeneration wet macular degeneration

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neovascular (WET) age-related macular degeneration (AMD)

Contacts and locations

Locations

  • "Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, UO Oculistica Dipartimento di Chirurgia"

    Milan, 20122, Italy

  • Akita University Hospital - Ophthalmology

    Akita, 010-8543, Japan

  • Asahikawa Medical University Hospital

    Asahikawa, Hokkaidô, 078-8510, Japan

  • Asan Medical Center

    Seoul, Seoul Teugbyeolsi, 05505, South Korea

  • Asociación para Evitar la Ceguera en México I.A.P.

    México DF, Mexico City, 04030, Mexico

  • Assaf Harofeh Medical Center

    Ẕerifin, 7030000, Israel

  • Associated Retina Consultants, Ltd. - Research

    Phoenix, Arizona, 85020, United States

  • Axon Clinical, s.r.o.

    Prague, 150 00, Czechia

  • Bajcsy-Zsilinszky Kórház és Rendelintézet

    Budapest, 1106, Hungary

  • Black Hills Regional Eye Institute - Ophthalmology

    Rapid City, South Dakota, 57701, United States

  • Bnai Zion Medical Center

    Haifa, Southern District, 3104802, Israel

  • Budapest Retina Intezet

    Budapest, 1133, Hungary

  • Center for Retina and Macular Disease

    Winter Haven, Florida, 33880, United States

  • Centro Medico Zambrano Hellion

    Monterrey, Nuevo León, 64710, Mexico

  • Centro de Retina Medica y Quirurgica S.C.

    Zapopan, 45116, Mexico

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

    Olsztyn, 10-424, Poland

  • Centrum Medyczne PROMED

    Krakow, 31-411, Poland

  • Centrum Medyczne UNO-MED

    Tarnów, 33-100, Poland

  • Charité Universitätsmedizin Berlin KöR

    Berlin, 12203, Germany

  • Charleston Neuroscience Institute

    Ladson, South Carolina, 29456, United States

  • Charlotte Eye Ear Nose & Throat Associates, P.A.

    Charlotte, North Carolina, 28210, United States

  • Clinical Center of Serbia

    Belgrade, 11000, Serbia

  • Clinique d'ophtalmologie des laurentides

    Boisbriand, Quebec, J7H 0E8, Canada

  • Colorado Retina Associates

    Lakewood, Colorado, 80228, United States

  • Debreceni Egyetem Klinikai Központ

    Debrecen, Hajdú-Bihar, 4032, Hungary

  • East Tallinn Central Hospital - Eye Clinic

    Tallinn, Harju, 10138, Estonia

  • Eye Care Specialists

    Kingston, Pennsylvania, 18704, United States

  • Eye Clinic of Dr. Krista Turman

    Tallinn, Harju, 11314, Estonia

  • Eye Clinic of Tartu University Hospital

    Tartu, Tartu, 50406, Estonia

  • FISABIO - Oftalmología Médica

    Valencia, 46015, Spain

  • FN Kralovske Vinohrady

    Prague, 100 34, Czechia

  • Fakultna nemocnica Trencin

    Trenčín, Treniansky Kraj, 911 71, Slovakia

  • Fakultna nemocnica s poliklinikou Zilina

    Žilina, Ilinský Kraj, 012 07, Slovakia

  • Florida Retina Consultants

    Lakeland, Florida, 33805, United States

  • Fondazione PTV Policlinico Tor Vergata, UNIT Patologie Retiniche

    Rome, Lazio, 00133, Italy

  • Fukushima Medical University Hospital - Ophthalmology

    Fukushima, Hukusima, 960-1295, Japan

  • Ganglion Orvosi Központ

    Pécs, Baranya, 7621, Hungary

  • Georgia Retina, P.C.

    Marietta, Georgia, 30060, United States

  • Hospital Clínico San Carlos

    Madrid, 28040, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Reina Sofía

    Córdoba, 14004, Spain

  • Hospital Universitario de Bellvitge

    LHospitalet de Llobregat, Barcelona, 8097, Spain

  • Jules Stein Eye Institute, UCLA

    Los Angeles, California, 90095-7000, United States

  • Kagoshima University Hospital - Ophthalmology

    Kagoshima, Kagoshima-ken, 890-8520, Japan

  • Kansai Medical University Hospital - Ophthalmology

    Hirakata, Ôsaka, 573-1191, Japan

  • Kaplan Medical Center

    Rehovot, 7610001, Israel

  • Klaipedos Universitetine ligoniene

    Klaipėda, Klaipdos Apskritis, LT-92288, Lithuania

  • Klinika Okulistyczna "Jasne Blonia"

    Lodz, Ódzkie, 91-134, Poland

  • Klinikum Darmstadt

    Darmstadt, Hesse, 64283, Germany

  • Korea University Anam Hospital - Ophthalmology

    Seoul, 02841, South Korea

  • Krajska zdravotni, a.s. Masarykova nemocnice v Usti n/ Labem

    Ústí nad Labem, Ústí Nad Labem, 401 13, Czechia

  • MH Egészségügyi Központ

    Budapest, H-1062, Hungary

  • Macula Care

    New York, New York, 10021, United States

  • Medeye Associates

    Miami, Florida, 33143, United States

  • Meir Medical Center

    Kfar Saba, Central District, 4428164, Israel

  • Mie University Hospital

    Tsu, Mie-ken, 514-8507, Japan

  • Miramar Eye Specialists

    Ventura, California, 93003, United States

  • Nagasaki University Hospital - Ophthalmology

    Nagasaki, 852-8501, Japan

  • Nagoya City University Hospital - Ophthalmology

    Nagoya, Aiti, 467-8602, Japan

  • Nagoya University Hospital

    Nagoya, Aiti, 466-8560, Japan

  • Nagoya University Hospital

    Nagoya, Aiti, Japan

  • Nihon University Hospital - Ophthalmology

    Tokyo, Tôkyô, 101-8309, Japan

  • Ocni klinika Pardubice

    Pardubice, 530 02, Czechia

  • Ophthalmic Consultants of the Capital Region - Ophthalmology

    Troy, New York, 12180, United States

  • Ophthalmology Associates

    Fort Worth, Texas, 76102, United States

  • Orange County Retina Medical Group

    Santa Ana, California, 92705, United States

  • P.Stradina Clinical University Hospital

    Riga, Rga, 1002, Latvia

  • Premiere Retina Specialists

    Midland, Texas, 79706, United States

  • Prince of Wales Hospital - Department of Ophthalmology and Visual Sciences

    Shatin, New Territories, 000000, Hong Kong

  • Profesorskie Centrum Okulistyki OKULISTYKA OPTIMUM

    Gdansk, Pomeranian Voivodeship, 80-809, Poland

  • Péterfy Kórház-Rendelintézet és Manninger Jen Országos Traumatológiai Intézet - Szemészeti Osztály

    Budapest, 1076, Hungary

  • Retina Associates IL

    Elmhurst, Illinois, 60126, United States

  • Retina Associates New Orleans

    Metairie, Louisiana, 70006, United States

  • Retina Associates of South Texas, P.A.

    San Antonio, Texas, 78240-1375, United States

  • Retina Center

    Saint Louis Park, Minnesota, 55416, United States

  • Retina Consultants San Diego

    Poway, California, 92064, United States

  • Retina Consultants of Houston

    The Woodlands, Texas, 77384, United States

  • Retina Consultants of Orange County

    Fullerton, California, 92835, United States

  • Retina Consultants of Southern California

    Redlands, California, 92374, United States

  • Retina Consultants of Texas Research Centers

    Bellaire, Texas, 77401, United States

  • Retina Group of New England

    Waterford, Connecticut, 06385, United States

  • Retina Research Institute of Texas

    Abilene, Texas, 79606, United States

  • Retina Vitreous Surgeons of Central NY, PC

    Liverpool, New York, 13088, United States

  • Retinal Consultants Medical Group, Inc.

    Sacramento, California, 95825, United States

  • Sabates Eye Center

    Leawood, Kansas, 66211, United States

  • Samsung Medical Center - Ophthalmology

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • Semmelweis Egyetem

    Budapest, H-1083, Hungary

  • Seoul National University Hospital - Department of Ophthalmology

    Seoul, Seoul Teugbyeolsi, 3080, South Korea

  • Signes Ozolinas Doctor Praxis in Ophthalmology

    Jelgava, LV- 3001, Latvia

  • Silmalaser OÜ

    Tallinn, Harju, 11412, Estonia

  • Soroka University Medical Center

    Beersheba, Southern District, 8410101, Israel

  • Southeast Retina Center

    Augusta, Georgia, 30909, United States

  • Southern California Desert Retina Consultants

    Palm Desert, California, 92211, United States

  • Specialty Eye Institute

    Jackson, Michigan, 49202, United States

  • St. Franziskus Hospital Münster

    Münster, North Rhine-Westphalia, 48145, Germany

  • Sterling Research Group

    Cincinnati, Ohio, 45219, United States

  • Strategic Clinical Research

    Willow Park, Texas, 76087, United States

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo

    Szeged, Csongrád megye, 6720, Hungary

  • Szpital Sw. Wojciecha

    Poznan, Greater Poland Voivodeship, 61-144, Poland

  • Texas Retina Associates

    Dallas, Texas, 75231, United States

  • Texas Retina Associates

    Fort Worth, Texas, 76012, United States

  • Texas Retina Associates

    Fort Worth, Texas, 76014, United States

  • The Catholic University of Korea, Seoul St. Mary's Hospital - Neurology

    Seoul, Seoul Teugbyeolsi, 06591, South Korea

  • The Retina Care Center

    Baltimore, Maryland, 21209, United States

  • The University of Hong Kong - Department of Ophthalmology

    Aberdeen, 000000, Hong Kong

  • UCSD Shiley Eye Institute, Jacobs Retina Center

    La Jolla, California, 92093, United States

  • UO Oftalmologia Ciardella Pol. S.Orsola Malpighi AOU di Bologna

    Bologna, 40138, Italy

  • UOC Oculistica Fondazione PU A.Gemelli IRCCS Un.Cattolica del Sacro Cuore

    Rome, Lazio, 00168, Italy

  • University Hospital Of Leipzig

    Leipzig, 04103, Germany

  • University Medical Center Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • University of Ottawa Eye Institute

    Ottawa, Ontario, K1H 8L6, Canada

  • University of Yamanashi Hospital

    Chūō, Yamanashi, 409-3898, Japan

  • Università degli Studi di Perugia, Ospedale Santa Maria della Misericordia, Clinica Oculistica

    Perugia, Umbria, 06129, Italy

  • Universitätsmedizin Göttingen

    Göttingen, Lower Saxony, 37075, Germany

  • Universitätsmedizin Mainz

    Mainz, Rhineland-Palatinate, 55131, Germany

  • Univerzitna nemocnica Bratislava

    Bratislava, Bratislava Region, 851 07, Slovakia

  • Vilniaus Universiteto Ligonines Santariskiu Klinikos (VULSK)

    Vilnius, Vilnius County, 8661, Lithuania

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08, Czechia

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