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]
NCT ID: NCT04270747
Last Updated: 2025-09-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
576 participants
INTERVENTIONAL
2020-06-22
2023-01-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ABP 938-Treatment Group A
Subjects 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.
ABP 938
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
Aflibercept-Treatment Group B1
Subjects 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.
Aflibercept
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
ABP 938-Treatment group B2
Subjects 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
ABP 938
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
Aflibercept
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
Interventions
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ABP 938
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
Aflibercept
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Associated Retina Consultants, Ltd. - Research
Phoenix, Arizona, United States
Retina Consultants of Orange County
Fullerton, California, United States
UCSD Shiley Eye Institute, Jacobs Retina Center
La Jolla, California, United States
Jules Stein Eye Institute, UCLA
Los Angeles, California, United States
Southern California Desert Retina Consultants
Palm Desert, California, United States
Retina Consultants San Diego
Poway, California, United States
Retina Consultants of Southern California
Redlands, California, United States
Retinal Consultants Medical Group, Inc.
Sacramento, California, United States
Orange County Retina Medical Group
Santa Ana, California, United States
Miramar Eye Specialists
Ventura, California, United States
Colorado Retina Associates
Lakewood, Colorado, United States
Retina Group of New England
Waterford, Connecticut, United States
Florida Retina Consultants
Lakeland, Florida, United States
Medeye Associates
Miami, Florida, United States
Center for Retina and Macular Disease
Winter Haven, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
Georgia Retina, P.C.
Marietta, Georgia, United States
Retina Associates IL
Elmhurst, Illinois, United States
Sabates Eye Center
Leawood, Kansas, United States
Retina Associates New Orleans
Metairie, Louisiana, United States
The Retina Care Center
Baltimore, Maryland, United States
Specialty Eye Institute
Jackson, Michigan, United States
Retina Center
Saint Louis Park, Minnesota, United States
Retina Vitreous Surgeons of Central NY, PC
Liverpool, New York, United States
Macula Care
New York, New York, United States
Ophthalmic Consultants of the Capital Region - Ophthalmology
Troy, New York, United States
Charlotte Eye Ear Nose & Throat Associates, P.A.
Charlotte, North Carolina, United States
Sterling Research Group
Cincinnati, Ohio, United States
Eye Care Specialists
Kingston, Pennsylvania, United States
Charleston Neuroscience Institute
Ladson, South Carolina, United States
Black Hills Regional Eye Institute - Ophthalmology
Rapid City, South Dakota, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Retina Consultants of Texas Research Centers
Bellaire, Texas, United States
Texas Retina Associates
Dallas, Texas, United States
Texas Retina Associates
Fort Worth, Texas, United States
Texas Retina Associates
Fort Worth, Texas, United States
Ophthalmology Associates
Fort Worth, Texas, United States
Premiere Retina Specialists
Midland, Texas, United States
Retina Associates of South Texas, P.A.
San Antonio, Texas, United States
Retina Consultants of Houston
The Woodlands, Texas, United States
Strategic Clinical Research
Willow Park, Texas, United States
University of Ottawa Eye Institute
Ottawa, Ontario, Canada
Clinique d'ophtalmologie des laurentides
Boisbriand, Quebec, Canada
Ocni klinika Pardubice
Pardubice, , Czechia
FN Kralovske Vinohrady
Prague, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Axon Clinical, s.r.o.
Prague, , Czechia
Krajska zdravotni, a.s. Masarykova nemocnice v Usti n/ Labem
Ústí nad Labem, Ústí Nad Labem, Czechia
East Tallinn Central Hospital - Eye Clinic
Tallinn, Harju, Estonia
Eye Clinic of Dr. Krista Turman
Tallinn, Harju, Estonia
Silmalaser OÜ
Tallinn, Harju, Estonia
Eye Clinic of Tartu University Hospital
Tartu, Tartu, Estonia
University Medical Center Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Klinikum Darmstadt
Darmstadt, Hesse, Germany
Universitätsmedizin Göttingen
Göttingen, Lower Saxony, Germany
St. Franziskus Hospital Münster
Münster, North Rhine-Westphalia, Germany
Universitätsmedizin Mainz
Mainz, Rhineland-Palatinate, Germany
Charité Universitätsmedizin Berlin KöR
Berlin, , Germany
University Hospital Of Leipzig
Leipzig, , Germany
The University of Hong Kong - Department of Ophthalmology
Aberdeen, , Hong Kong
Prince of Wales Hospital - Department of Ophthalmology and Visual Sciences
Shatin, New Territories, , Hong Kong
Ganglion Orvosi Központ
Pécs, Baranya, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo
Szeged, Csongrád megye, Hungary
Debreceni Egyetem Klinikai Központ
Debrecen, Hajdú-Bihar, Hungary
Péterfy Kórház-Rendelintézet és Manninger Jen Országos Traumatológiai Intézet - Szemészeti Osztály
Budapest, , Hungary
Bajcsy-Zsilinszky Kórház és Rendelintézet
Budapest, , Hungary
Budapest Retina Intezet
Budapest, , Hungary
MH Egészségügyi Központ
Budapest, , Hungary
Semmelweis Egyetem
Budapest, , Hungary
Meir Medical Center
Kfar Saba, Central District, Israel
Soroka University Medical Center
Beersheba, Southern District, Israel
Bnai Zion Medical Center
Haifa, Southern District, Israel
Kaplan Medical Center
Rehovot, , Israel
Assaf Harofeh Medical Center
Ẕerifin, , Israel
Fondazione PTV Policlinico Tor Vergata, UNIT Patologie Retiniche
Rome, Lazio, Italy
UOC Oculistica Fondazione PU A.Gemelli IRCCS Un.Cattolica del Sacro Cuore
Rome, Lazio, Italy
Università degli Studi di Perugia, Ospedale Santa Maria della Misericordia, Clinica Oculistica
Perugia, Umbria, Italy
UO Oftalmologia Ciardella Pol. S.Orsola Malpighi AOU di Bologna
Bologna, , Italy
"Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, UO Oculistica Dipartimento di Chirurgia"
Milan, , Italy
Nagoya University Hospital
Nagoya, Aiti, Japan
Nagoya City University Hospital - Ophthalmology
Nagoya, Aiti, Japan
Nagoya University Hospital
Nagoya, Aiti, Japan
Asahikawa Medical University Hospital
Asahikawa, Hokkaidô, Japan
Fukushima Medical University Hospital - Ophthalmology
Fukushima, Hukusima, Japan
Kagoshima University Hospital - Ophthalmology
Kagoshima, Kagoshima-ken, Japan
Mie University Hospital
Tsu, Mie-ken, Japan
Nihon University Hospital - Ophthalmology
Tokyo, Tôkyô, Japan
University of Yamanashi Hospital
Chūō, Yamanashi, Japan
Akita University Hospital - Ophthalmology
Akita, , Japan
Nagasaki University Hospital - Ophthalmology
Nagasaki, , Japan
Kansai Medical University Hospital - Ophthalmology
Hirakata, Ôsaka, Japan
P.Stradina Clinical University Hospital
Riga, Rga, Latvia
Signes Ozolinas Doctor Praxis in Ophthalmology
Jelgava, , Latvia
Klaipedos Universitetine ligoniene
Klaipėda, Klaipdos Apskritis, Lithuania
Vilniaus Universiteto Ligonines Santariskiu Klinikos (VULSK)
Vilnius, Vilnius County, Lithuania
Asociación para Evitar la Ceguera en México I.A.P.
México DF, Mexico City, Mexico
Centro Medico Zambrano Hellion
Monterrey, Nuevo León, Mexico
Centro de Retina Medica y Quirurgica S.C.
Zapopan, , Mexico
Szpital Sw. Wojciecha
Poznan, Greater Poland Voivodeship, Poland
Profesorskie Centrum Okulistyki OKULISTYKA OPTIMUM
Gdansk, Pomeranian Voivodeship, Poland
Centrum Medyczne PROMED
Krakow, , Poland
Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.
Olsztyn, , Poland
Centrum Medyczne UNO-MED
Tarnów, , Poland
Klinika Okulistyczna "Jasne Blonia"
Lodz, Ódzkie, Poland
Clinical Center of Serbia
Belgrade, , Serbia
Univerzitna nemocnica Bratislava
Bratislava, Bratislava Region, Slovakia
Fakultna nemocnica s poliklinikou Zilina
Žilina, Ilinský Kraj, Slovakia
Fakultna nemocnica Trencin
Trenčín, Treniansky Kraj, Slovakia
Asan Medical Center
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center - Ophthalmology
Seoul, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital - Neurology
Seoul, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital - Department of Ophthalmology
Seoul, Seoul Teugbyeolsi, South Korea
Korea University Anam Hospital - Ophthalmology
Seoul, , South Korea
Hospital Universitario de Bellvitge
LHospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Reina Sofía
Córdoba, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
FISABIO - Oftalmología Médica
Valencia, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2019-002503-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20170542
Identifier Type: -
Identifier Source: org_study_id
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