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 Randomized, Double-masked, Phase 3 Study of ABP 938 Efficacy and Safety Compared to Aflibercept (Eylea®) in Subjects With Neovascular Age-related Macular Degeneration
2 other identifiers
interventional
576
17 countries
114
Brief 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) administered by intravitreal (IVT) injection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2020
Typical duration for phase_3
114 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2020
CompletedFirst Posted
Study publicly available on registry
February 17, 2020
CompletedStudy Start
First participant enrolled
June 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2023
CompletedResults Posted
Study results publicly available
January 5, 2024
CompletedSeptember 10, 2025
September 1, 2025
2.1 years
February 13, 2020
December 14, 2023
September 8, 2025
Conditions
Outcome Measures
Primary Outcomes (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.
Baseline and Week 8
Secondary Outcomes (8)
Percentage of Participants Who Maintained Vision at Week 52
Week 52
Mean Change From Baseline in BCVA
Baseline and Weeks 4, 8, 16, 24, 32, 40, 48, and 52
Percentage of Participants Who Gained at Least 10 Letters of Vision at Week 8
Week 8
Percentage of Participants Who Gained at Least 15 Letters of Vision at Week 52
Week 52
Mean Change From Baseline in Choroidal Neovascularization (CNV) Area Size
Baseline and Weeks 8, 16, 24, and 52
- +3 more secondary outcomes
Study Arms (3)
ABP 938-Treatment Group A
EXPERIMENTALSubjects 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.
Aflibercept-Treatment Group B1
ACTIVE 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.
ABP 938-Treatment group B2
ACTIVE 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
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +27 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (118)
Associated Retina Consultants, Ltd. - Research
Phoenix, Arizona, 85020, United States
Retina Consultants of Orange County
Fullerton, California, 92835, United States
UCSD Shiley Eye Institute, Jacobs Retina Center
La Jolla, California, 92093, United States
Jules Stein Eye Institute, UCLA
Los Angeles, California, 90095-7000, United States
Southern California Desert Retina Consultants
Palm Desert, California, 92211, United States
Retina Consultants San Diego
Poway, California, 92064, United States
Retina Consultants of Southern California
Redlands, California, 92374, United States
Retinal Consultants Medical Group, Inc.
Sacramento, California, 95825, United States
Orange County Retina Medical Group
Santa Ana, California, 92705, United States
Miramar Eye Specialists
Ventura, California, 93003, United States
Colorado Retina Associates
Lakewood, Colorado, 80228, United States
Retina Group of New England
Waterford, Connecticut, 06385, United States
Florida Retina Consultants
Lakeland, Florida, 33805, United States
Medeye Associates
Miami, Florida, 33143, United States
Center for Retina and Macular Disease
Winter Haven, Florida, 33880, United States
Southeast Retina Center
Augusta, Georgia, 30909, United States
Georgia Retina, P.C.
Marietta, Georgia, 30060, United States
Retina Associates IL
Elmhurst, Illinois, 60126, United States
Sabates Eye Center
Leawood, Kansas, 66211, United States
Retina Associates New Orleans
Metairie, Louisiana, 70006, United States
The Retina Care Center
Baltimore, Maryland, 21209, United States
Specialty Eye Institute
Jackson, Michigan, 49202, United States
Retina Center
Saint Louis Park, Minnesota, 55416, United States
Retina Vitreous Surgeons of Central NY, PC
Liverpool, New York, 13088, United States
Macula Care
New York, New York, 10021, United States
Ophthalmic Consultants of the Capital Region - Ophthalmology
Troy, New York, 12180, United States
Charlotte Eye Ear Nose & Throat Associates, P.A.
Charlotte, North Carolina, 28210, United States
Sterling Research Group
Cincinnati, Ohio, 45219, United States
Eye Care Specialists
Kingston, Pennsylvania, 18704, United States
Charleston Neuroscience Institute
Ladson, South Carolina, 29456, United States
Black Hills Regional Eye Institute - Ophthalmology
Rapid City, South Dakota, 57701, United States
Retina Research Institute of Texas
Abilene, Texas, 79606, United States
Retina Consultants of Texas Research Centers
Bellaire, Texas, 77401, United States
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
Ophthalmology Associates
Fort Worth, Texas, 76102, United States
Premiere Retina Specialists
Midland, Texas, 79706, United States
Retina Associates of South Texas, P.A.
San Antonio, Texas, 78240-1375, United States
Retina Consultants of Houston
The Woodlands, Texas, 77384, United States
Strategic Clinical Research
Willow Park, Texas, 76087, United States
University of Ottawa Eye Institute
Ottawa, Ontario, K1H 8L6, Canada
Clinique d'ophtalmologie des laurentides
Boisbriand, Quebec, J7H 0E8, Canada
Ocni klinika Pardubice
Pardubice, 530 02, Czechia
FN Kralovske Vinohrady
Prague, 100 34, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, Czechia
Axon Clinical, s.r.o.
Prague, 150 00, Czechia
Krajska zdravotni, a.s. Masarykova nemocnice v Usti n/ Labem
Ústí nad Labem, Ústí Nad Labem, 401 13, Czechia
East Tallinn Central Hospital - Eye Clinic
Tallinn, Harju, 10138, Estonia
Eye Clinic of Dr. Krista Turman
Tallinn, Harju, 11314, Estonia
Silmalaser OÜ
Tallinn, Harju, 11412, Estonia
Eye Clinic of Tartu University Hospital
Tartu, Tartu, 50406, Estonia
University Medical Center Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Klinikum Darmstadt
Darmstadt, Hesse, 64283, Germany
Universitätsmedizin Göttingen
Göttingen, Lower Saxony, 37075, Germany
St. Franziskus Hospital Münster
Münster, North Rhine-Westphalia, 48145, Germany
Universitätsmedizin Mainz
Mainz, Rhineland-Palatinate, 55131, Germany
Charité Universitätsmedizin Berlin KöR
Berlin, 12203, Germany
University Hospital Of Leipzig
Leipzig, 04103, Germany
The University of Hong Kong - Department of Ophthalmology
Aberdeen, 000000, Hong Kong
Prince of Wales Hospital - Department of Ophthalmology and Visual Sciences
Shatin, New Territories, 000000, Hong Kong
Ganglion Orvosi Központ
Pécs, Baranya, 7621, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo
Szeged, Csongrád megye, 6720, Hungary
Debreceni Egyetem Klinikai Központ
Debrecen, Hajdú-Bihar, 4032, Hungary
Péterfy Kórház-Rendelintézet és Manninger Jen Országos Traumatológiai Intézet - Szemészeti Osztály
Budapest, 1076, Hungary
Bajcsy-Zsilinszky Kórház és Rendelintézet
Budapest, 1106, Hungary
Budapest Retina Intezet
Budapest, 1133, Hungary
MH Egészségügyi Központ
Budapest, H-1062, Hungary
Semmelweis Egyetem
Budapest, H-1083, Hungary
Meir Medical Center
Kfar Saba, Central District, 4428164, Israel
Soroka University Medical Center
Beersheba, Southern District, 8410101, Israel
Bnai Zion Medical Center
Haifa, Southern District, 3104802, Israel
Kaplan Medical Center
Rehovot, 7610001, Israel
Assaf Harofeh Medical Center
Ẕerifin, 7030000, Israel
Fondazione PTV Policlinico Tor Vergata, UNIT Patologie Retiniche
Rome, Lazio, 00133, Italy
UOC Oculistica Fondazione PU A.Gemelli IRCCS Un.Cattolica del Sacro Cuore
Rome, Lazio, 00168, Italy
Università degli Studi di Perugia, Ospedale Santa Maria della Misericordia, Clinica Oculistica
Perugia, Umbria, 06129, Italy
UO Oftalmologia Ciardella Pol. S.Orsola Malpighi AOU di Bologna
Bologna, 40138, Italy
"Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, UO Oculistica Dipartimento di Chirurgia"
Milan, 20122, Italy
Nagoya University Hospital
Nagoya, Aiti, 466-8560, Japan
Nagoya City University Hospital - Ophthalmology
Nagoya, Aiti, 467-8602, Japan
Nagoya University Hospital
Nagoya, Aiti, Japan
Asahikawa Medical University Hospital
Asahikawa, Hokkaidô, 078-8510, Japan
Fukushima Medical University Hospital - Ophthalmology
Fukushima, Hukusima, 960-1295, Japan
Kagoshima University Hospital - Ophthalmology
Kagoshima, Kagoshima-ken, 890-8520, Japan
Mie University Hospital
Tsu, Mie-ken, 514-8507, Japan
Nihon University Hospital - Ophthalmology
Tokyo, Tôkyô, 101-8309, Japan
University of Yamanashi Hospital
Chūō, Yamanashi, 409-3898, Japan
Akita University Hospital - Ophthalmology
Akita, 010-8543, Japan
Nagasaki University Hospital - Ophthalmology
Nagasaki, 852-8501, Japan
Kansai Medical University Hospital - Ophthalmology
Hirakata, Ôsaka, 573-1191, Japan
P.Stradina Clinical University Hospital
Riga, Rga, 1002, Latvia
Signes Ozolinas Doctor Praxis in Ophthalmology
Jelgava, LV- 3001, Latvia
Klaipedos Universitetine ligoniene
Klaipėda, Klaipdos Apskritis, LT-92288, Lithuania
Vilniaus Universiteto Ligonines Santariskiu Klinikos (VULSK)
Vilnius, Vilnius County, 8661, Lithuania
Asociación para Evitar la Ceguera en México I.A.P.
México DF, Mexico City, 04030, Mexico
Centro Medico Zambrano Hellion
Monterrey, Nuevo León, 64710, Mexico
Centro de Retina Medica y Quirurgica S.C.
Zapopan, 45116, Mexico
Szpital Sw. Wojciecha
Poznan, Greater Poland Voivodeship, 61-144, Poland
Profesorskie Centrum Okulistyki OKULISTYKA OPTIMUM
Gdansk, Pomeranian Voivodeship, 80-809, Poland
Centrum Medyczne PROMED
Krakow, 31-411, Poland
Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.
Olsztyn, 10-424, Poland
Centrum Medyczne UNO-MED
Tarnów, 33-100, Poland
Klinika Okulistyczna "Jasne Blonia"
Lodz, Ódzkie, 91-134, Poland
Clinical Center of Serbia
Belgrade, 11000, Serbia
Univerzitna nemocnica Bratislava
Bratislava, Bratislava Region, 851 07, Slovakia
Fakultna nemocnica s poliklinikou Zilina
Žilina, Ilinský Kraj, 012 07, Slovakia
Fakultna nemocnica Trencin
Trenčín, Treniansky Kraj, 911 71, Slovakia
Asan Medical Center
Seoul, Seoul Teugbyeolsi, 05505, South Korea
Samsung Medical Center - Ophthalmology
Seoul, Seoul Teugbyeolsi, 06351, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital - Neurology
Seoul, Seoul Teugbyeolsi, 06591, South Korea
Seoul National University Hospital - Department of Ophthalmology
Seoul, Seoul Teugbyeolsi, 3080, South Korea
Korea University Anam Hospital - Ophthalmology
Seoul, 02841, South Korea
Hospital Universitario de Bellvitge
LHospitalet de Llobregat, Barcelona, 8097, Spain
Hospital Universitario Reina Sofía
Córdoba, 14004, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
FISABIO - Oftalmología Médica
Valencia, 46015, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- The study is double-masked; therefore, the investigators, study personnel, and the study subjects will remain masked to treatment allocation. Unmasking is only allowed in the case of an emergency, when knowledge of the investigational product is essential for the clinical management of the subject.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2020
First Posted
February 17, 2020
Study Start
June 22, 2020
Primary Completion
July 18, 2022
Study Completion
January 30, 2023
Last Updated
September 10, 2025
Results First Posted
January 5, 2024
Record last verified: 2025-09