AzTrials
AzTrials

Neovascular (Wet) Age-related Macular Degeneration (AMD)Phase 3NCT04270747

A Study to Understand Effectiveness and Safety of ABP 938 Compared to Aflibercept (Eylea®) in Patients Suffering With Neovascular Age-related Macular Degeneration [Neovascular (Wet) AMD]

A Phase 3 study testing ABP 938 and Aflibercept in people with Neovascular (Wet) Age-related Macular Degeneration (AMD), run by Amgen at 118 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to compare the efficacy and safety of ABP 938 versus Aflibercept (Eylea®) in the treatment of neovascular age-related macular degeneration. Subjects will be randomized in a masked 1:1 ratio to receive 2 mg (0.05 mL) of either ABP 938 (Treatment Group A) or aflibercept (Treatment Group B)… Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
ABP 938 and Aflibercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
576 participants
Where
118 sitesin 18 countries
Study dates
22 Jun 2020to 30 Jan 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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

Who cannot join

  • 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
Show all 42Show fewer
  • 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

Trial locations and contacts

118 sites in 18 countries.

118 sites in 18 countries

United States41 sites

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • The Retina Care Center

    Baltimore, Maryland, 21209

  • Retina Consultants of Texas Research Centers

    Bellaire, Texas, 77401

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

    Charlotte, North Carolina, 28210

  • Sterling Research Group

    Cincinnati, Ohio, 45219

  • Texas Retina Associates

    Dallas, Texas, 75231

  • Retina Associates IL

    Elmhurst, Illinois, 60126

  • Texas Retina Associates

    Fort Worth, Texas, 76012

  • Texas Retina Associates

    Fort Worth, Texas, 76014

  • Ophthalmology Associates

    Fort Worth, Texas, 76102

  • Retina Consultants of Orange County

    Fullerton, California, 92835

  • Specialty Eye Institute

    Jackson, Michigan, 49202

  • Eye Care Specialists

    Kingston, Pennsylvania, 18704

  • UCSD Shiley Eye Institute, Jacobs Retina Center

    La Jolla, California, 92093

  • Charleston Neuroscience Institute

    Ladson, South Carolina, 29456

  • Florida Retina Consultants

    Lakeland, Florida, 33805

  • Colorado Retina Associates

    Lakewood, Colorado, 80228

  • Sabates Eye Center

    Leawood, Kansas, 66211

  • Retina Vitreous Surgeons of Central NY, PC

    Liverpool, New York, 13088

  • Jules Stein Eye Institute, UCLA

    Los Angeles, California, 90095-7000

  • Georgia Retina, P.C.

    Marietta, Georgia, 30060

  • Retina Associates New Orleans

    Metairie, Louisiana, 70006

  • Medeye Associates

    Miami, Florida, 33143

  • Premiere Retina Specialists

    Midland, Texas, 79706

  • Macula Care

    New York, New York, 10021

  • Southern California Desert Retina Consultants

    Palm Desert, California, 92211

  • Associated Retina Consultants, Ltd. - Research

    Phoenix, Arizona, 85020

  • Retina Consultants San Diego

    Poway, California, 92064

  • Black Hills Regional Eye Institute - Ophthalmology

    Rapid City, South Dakota, 57701

  • Retina Consultants of Southern California

    Redlands, California, 92374

  • Retinal Consultants Medical Group, Inc.

    Sacramento, California, 95825

  • Retina Center

    Saint Louis Park, Minnesota, 55416

  • Retina Associates of South Texas, P.A.

    San Antonio, Texas, 78240-1375

  • Orange County Retina Medical Group

    Santa Ana, California, 92705

  • Retina Consultants of Houston

    The Woodlands, Texas, 77384

  • Ophthalmic Consultants of the Capital Region - Ophthalmology

    Troy, New York, 12180

  • Miramar Eye Specialists

    Ventura, California, 93003

  • Retina Group of New England

    Waterford, Connecticut, 06385

  • Strategic Clinical Research

    Willow Park, Texas, 76087

  • Center for Retina and Macular Disease

    Winter Haven, Florida, 33880

Other trials in United States

Japan12 sites

  • Akita University Hospital - Ophthalmology

    Akita, 010-8543

  • Asahikawa Medical University Hospital

    Asahikawa, Hokkaidô, 078-8510

  • University of Yamanashi Hospital

    Chūō, Yamanashi, 409-3898

  • Fukushima Medical University Hospital - Ophthalmology

    Fukushima, Hukusima, 960-1295

  • Kansai Medical University Hospital - Ophthalmology

    Hirakata, Ôsaka, 573-1191

  • Kagoshima University Hospital - Ophthalmology

    Kagoshima, Kagoshima-ken, 890-8520

  • Nagasaki University Hospital - Ophthalmology

    Nagasaki, 852-8501

  • Nagoya University Hospital

    Nagoya, Aiti, 466-8560

  • Nagoya City University Hospital - Ophthalmology

    Nagoya, Aiti, 467-8602

  • Nagoya University Hospital

    Nagoya, Aiti

  • Nihon University Hospital - Ophthalmology

    Tokyo, Tôkyô, 101-8309

  • Mie University Hospital

    Tsu, Mie-ken, 514-8507

Other trials in Japan

Hungary8 sites

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

    Budapest, 1076

  • Bajcsy-Zsilinszky Kórház és Rendelintézet

    Budapest, 1106

  • Budapest Retina Intezet

    Budapest, 1133

  • MH Egészségügyi Központ

    Budapest, H-1062

  • Semmelweis Egyetem

    Budapest, H-1083

  • Debreceni Egyetem Klinikai Központ

    Debrecen, Hajdú-Bihar, 4032

  • Ganglion Orvosi Központ

    Pécs, Baranya, 7621

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo

    Szeged, Csongrád megye, 6720

Other trials in Hungary

Germany7 sites

  • Charité Universitätsmedizin Berlin KöR

    Berlin, 12203

  • Klinikum Darmstadt

    Darmstadt, Hesse, 64283

  • University Medical Center Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Universitätsmedizin Göttingen

    Göttingen, Lower Saxony, 37075

  • University Hospital Of Leipzig

    Leipzig, 04103

  • Universitätsmedizin Mainz

    Mainz, Rhineland-Palatinate, 55131

  • St. Franziskus Hospital Münster

    Münster, North Rhine-Westphalia, 48145

Other trials in Germany

Poland6 sites

  • Profesorskie Centrum Okulistyki OKULISTYKA OPTIMUM

    Gdansk, Pomeranian Voivodeship, 80-809

  • Centrum Medyczne PROMED

    Krakow, 31-411

  • Klinika Okulistyczna "Jasne Blonia"

    Lodz, Ódzkie, 91-134

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

    Olsztyn, 10-424

  • Szpital Sw. Wojciecha

    Poznan, Greater Poland Voivodeship, 61-144

  • Centrum Medyczne UNO-MED

    Tarnów, 33-100

Other trials in Poland

Czechia5 sites

  • Ocni klinika Pardubice

    Pardubice, 530 02

  • FN Kralovske Vinohrady

    Prague, 100 34

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

  • Axon Clinical, s.r.o.

    Prague, 150 00

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

    Ústí nad Labem, Ústí Nad Labem, 401 13

Other trials in Czechia

Israel5 sites

  • Soroka University Medical Center

    Beersheba, Southern District, 8410101

  • Bnai Zion Medical Center

    Haifa, Southern District, 3104802

  • Meir Medical Center

    Kfar Saba, Central District, 4428164

  • Kaplan Medical Center

    Rehovot, 7610001

  • Assaf Harofeh Medical Center

    Tsrifin, 7030000

Other trials in Israel

Italy5 sites

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

    Bologna, 40138

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

    Milan, 20122

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

    Perugia, Umbria, 06129

  • Fondazione PTV Policlinico Tor Vergata, UNIT Patologie Retiniche

    Rome, Lazio, 00133

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

    Rome, Lazio, 00168

Other trials in Italy

South Korea5 sites

  • Asan Medical Center

    Seoul, Seoul Teugbyeolsi, 05505

  • Samsung Medical Center - Ophthalmology

    Seoul, Seoul Teugbyeolsi, 06351

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

    Seoul, Seoul Teugbyeolsi, 06591

  • Seoul National University Hospital - Department of Ophthalmology

    Seoul, Seoul Teugbyeolsi, 3080

  • Korea University Anam Hospital - Ophthalmology

    Seoul, 02841

Other trials in South Korea

Spain5 sites

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

  • Hospital Universitario de Bellvitge

    LHospitalet de Llobregat, Barcelona, 8097

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • FISABIO - Oftalmología Médica

    Valencia, 46015

Other trials in Spain

Estonia4 sites

  • East Tallinn Central Hospital - Eye Clinic

    Tallinn, Harju, 10138

  • Eye Clinic of Dr. Krista Turman

    Tallinn, Harju, 11314

  • Silmalaser OÜ

    Tallinn, Harju, 11412

  • Eye Clinic of Tartu University Hospital

    Tartu, Tartu, 50406

Other trials in Estonia

Mexico3 sites

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

    México DF, Mexico City, 04030

  • Centro Medico Zambrano Hellion

    Monterrey, Nuevo León, 64710

  • Centro de Retina Medica y Quirurgica S.C.

    Zapopan, 45116

Other trials in Mexico

Slovakia3 sites

  • Univerzitna nemocnica Bratislava

    Bratislava, Bratislava Region, 851 07

  • Fakultna nemocnica Trencin

    Trenčín, Treniansky Kraj, 911 71

  • Fakultna nemocnica s poliklinikou Zilina

    Žilina, Ilinský Kraj, 012 07

Other trials in Slovakia

Canada2 sites

  • Clinique d'ophtalmologie des laurentides

    Boisbriand, Quebec, J7H 0E8

  • University of Ottawa Eye Institute

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

Hong Kong2 sites

  • The University of Hong Kong - Department of Ophthalmology

    Aberdeen, 000000

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

    Shatin, New Territories, 000000

Other trials in Hong Kong

Latvia2 sites

  • Signes Ozolinas Doctor Praxis in Ophthalmology

    Jelgava, LV- 3001

  • P.Stradina Clinical University Hospital

    Riga, Rga, 1002

Other trials in Latvia

Lithuania2 sites

  • Klaipedos Universitetine ligoniene

    Klaipėda, Klaipdos Apskritis, LT-92288

  • Vilniaus Universiteto Ligonines Santariskiu Klinikos (VULSK)

    Vilnius, Vilnius County, 8661

Other trials in Lithuania

Serbia1 site

  • Clinical Center of Serbia

    Belgrade, 11000

Other trials in Serbia

About this study

Official title: A Randomized, Double-masked, Phase 3 Study of ABP 938 Efficacy and Safety Compared to Aflibercept (Eylea®) in Subjects With Neovascular Age-related Macular Degeneration

The purpose of this study is to compare the efficacy and safety of ABP 938 versus Aflibercept (Eylea®) in the treatment of neovascular age-related macular degeneration. Subjects will be randomized in a masked 1:1 ratio to receive 2 mg (0.05 mL) of either ABP 938 (Treatment Group A) or aflibercept (Treatment Group B) administered by intravitreal (IVT) injection.

Read the detailed description

Approximately 566 subjects will be randomized in approximately 126 global sites.

This study consists of a screening period of up to 4 weeks, after which subjects will receive investigational product for 48 weeks, followed by a safety follow-up period to week 52, for a total study duration of up to 56 weeks.

Subjects will be randomized in a masked 1:1 ratio to receive 2 mg (0.05 mL) of either ABP 938 (Treatment Group A) or aflibercept (Treatment Group B) administered by IVT injection.

At week 8, subjects will be assessed for the primary endpoint. The primary endpoint is the change in Best Corrected Visual Acuity (BCVA) as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score from baseline to week 8, in order to assess the efficacy of ABP 938 compared to aflibercept.

Subjects will then be re-randomized at week 16 in a masked fashion such that:

  • Subjects initially randomized to ABP 938 (Treatment Group A) will continue to receive ABP 938 by IVT injection every 8 weeks from week 16 until week 48
  • Subjects initially randomized to aflibercept (Treatment Group B) will be re-randomized in a 1:1 ratio to either continue on aflibercept (Treatment Group B1) or transition to ABP 938 (Treatment Group B2) by IVT injection every 8 weeks from week 16 until week 48
Being tested
ABP 938, Aflibercept
Medical subject headings
Macular Degeneration

What participants receive

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

  • ABP 938Drug

    Subject will receive ABP 938 2 mg (0.05 mL) IVT injection every 4 weeks for the first 3 doses, followed by once every 8 weeks

  • AfliberceptDrug

    Also called Eylea®

    Subject will receive aflibercept 2 mg (0.05 mL) IVT injection every 4 weeks for the first 3 doses, followed by once every 8 weeks

Study groups in NCT04270747
Study groupRoleWhat they receive
ABP 938-Treatment Group AExperimentalSubjects will receive 2 mg (0.05 mL) of ABP 938 by intravitreal (IVT) injection every 4 weeks for the first 3 doses (ie, baseline/day 1, week 4, and week 8) and every 8 weeks from week 16 until week 48.
Receives: Drug: ABP 938
Aflibercept-Treatment Group B1Active comparatorSubjects will receive 2 mg (0.05 mL) of aflibercept (Treatment Group B) by IVT injection every 4 weeks for the first 3 doses (ie, baseline/day 1, week 4, and week 8). Subjects will be re-randomized to receive aflibercept by IVT injection every 8 weeks from week 16 until week 48.
Receives: Drug: Aflibercept
ABP 938-Treatment group B2Active comparatorSubjects will receive 2 mg (0.05 mL) of aflibercept (Treatment Group B) by IVT injection every 4 weeks for the first 3 doses (ie, baseline/day 1, week 4, and week 8). Subjects will be re-randomized to receive ABP 938 by IVT injection every 8 weeks from week 16 until week 48
Receives: Drug: ABP 938; Drug: Aflibercept

What is being measured

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

  1. Mean Change From Baseline in BCVA at Week 8

    BCVA score was assessed based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart by the study eye at 4 meters. ETDRS letters score could range from 0 to 100 letters at each assessment.

    A positive change from Baseline in ETDRS letter score indicated an improvement in visual acuity in the study eye. Change from Baseline calculated as observed post-baseline value - Baseline value.

    Measured: Baseline and Week 8

Secondary outcomes (8)

  1. Percentage of Participants Who Maintained Vision at Week 52

    A participant was classified as maintaining vision if he/she lost fewer than 15 letters in ETDRS letter score, assessed in the study eye, compared to Baseline.

    Measured: Week 52

  2. Mean Change From Baseline in BCVA

    BCVA score was assessed based on the number of letters read correctly on the ETDRS chart by the study eye at 4 meters. ETDRS letters score could range from 0 to 100 letters at each assessment.

    A positive change from Baseline in ETDRS letter score indicated an improvement in visual acuity in the study eye. Change from Baseline calculated as observed post-baseline value - Baseline value.

    Measured: Baseline and Weeks 4, 8, 16, 24, 32, 40, 48, and 52

  3. Percentage of Participants Who Gained at Least 10 Letters of Vision at Week 8

    Percentage of participants who gained at least 10 letters of vision was assessed based on the number of letters read correctly on the ETDRS chart by the study eye at 4 meters. ETDRS letters score could range from 0 to 100 letters at each assessment.

    Measured: Week 8

  4. Percentage of Participants Who Gained at Least 15 Letters of Vision at Week 52

    Percentage of participants who gained at least 15 letters of vision was assessed based on the number of letters read correctly on the ETDRS chart by the study eye at 4 meters. ETDRS letters score could range from 0 to 100 letters at each assessment.

    Measured: Week 52

  5. Mean Change From Baseline in Choroidal Neovascularization (CNV) Area Size

    CNV area size was measured by fluorescein angiography.

    Change from Baseline calculated as observed post-baseline value - Baseline value.

    Measured: Baseline and Weeks 8, 16, 24, and 52

  6. Mean Change From Baseline in Central Subfield Thickness (CST)

    CST was defined as the average thickness in the ETDRS central 1 mm diameter subfield (the central subfield) and was measured by spectral domain optical coherence tomography.

    Change from Baseline calculated as observed post-baseline value - Baseline value.

    Measured: Baseline and Weeks 4, 8, 16, 24, 32, 40, 48, and 52

  7. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    An adverse event (AE) is any untoward medical occurrence in a clinical trial participant. TEAEs were defined as those AEs that begin or increase in severity or frequency at or after the time of first treatment to the End of Study visit. Events of interest (EOIs) pre-specified for this study included endophthalmitis, retinal detachment, increase in intraocular pressure, and thromboembolic events. Serious AEs were defined as any untoward medical occurrence that meets at least 1 of the following serious criteria:

    • Results in death
    • Life-threatening
    • Requires inpatient hospitalization or prolongation of existing hospitalization
    • Results in persistent or significant disability/incapacity
    • Congenital anomaly/birth defect
    • Other medically important serious event.

    Measured: Up to Week 52

  8. Number of Participants Developing Binding Antidrug Antibodies (ADAs)

    Number of participants with positive post-baseline ADA result through Week 16 and post Week 16 with negative or no result at Baseline is reported.

    Measured: Baseline up to Week 52

Timeline

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

  1. First posted17 Feb 2020
  2. Study start22 Jun 2020
  3. Primary completion18 Jul 2022
  4. Study completion30 Jan 2023

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
576 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04270747
Sponsor's protocol ID
20170542
Other IDs
2019-002503-17, 2019
Status last verified
Sep 2025
First submitted
13 Feb 2020
Last updated
10 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Chow V, Zhou M, Mytych DT, Colbert A, Miller MJ, Wala I, Sabet A, Radziszewski W. Pharmacokinetic, Safety, and Immunogenicity Similarity of High- and Low-Concentration Formulations of Adalimumab Biosimilar ABP 501, Adalimumab-Atto. Pharmacol Res Perspect. 2026 Apr;14(2):e70236. doi: 10.1002/prp2.70236.

    PubMed 41857488

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ABP 938 and Aflibercept in people with Neovascular (Wet) Age-related Macular Degeneration (AMD), run by Amgen at 118 sites in 18 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 7 inclusion and 42 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: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in United States, Japan, Hungary, Germany, Poland and 13 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?

Yes. Results are posted in the registry (first posted 5 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in BCVA at Week 8 (time frame: Baseline and Week 8). 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 NCT04270747, which also lists 1 linked publication.

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 10 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in