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

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.

Study Overview

• Status: Completed
• Conditions: Neovascular (Wet) Age-related Macular Degeneration (AMD)
• Intervention / Treatment: Drug: ABP 938; Drug: Aflibercept

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

• Study Type: Interventional
• Enrollment (Actual): 576
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • University of Ottawa Eye Institute
  • Quebec
    • Boisbriand, Quebec, Canada, J7H 0E8
      • Clinique d'ophtalmologie des laurentides
• Czechia
  • Pardubice, Czechia, 530 02
    • Ocni klinika Pardubice
  • Praha 10, Czechia, 100 34
    • FN Kralovske Vinohrady
  • Praha 2, Czechia, 128 08
    • Vseobecna fakultni nemocnice v Praze
  • Praha 5, Czechia, 150 00
    • Axon Clinical, s.r.o.
  • Ústí Nad Labem
    • Usti nad Labem, Ústí Nad Labem, Czechia, 401 13
      • Krajska zdravotni, a.s. Masarykova nemocnice v Usti n/ Labem
• Estonia
  • Harjumaa
    • Tallinn, Harjumaa, Estonia, 10138
      • East Tallinn Central Hospital - Eye Clinic
    • Tallinn, Harjumaa, Estonia, 11314
      • Eye Clinic of Dr. Krista Turman
    • Tallinn, Harjumaa, Estonia, 11412
      • Silmalaser OÜ
  • Tartumaa
    • Tartu, Tartumaa, Estonia, 50406
      • Eye Clinic of Tartu University Hospital
• Germany
  • Berlin, Germany, 12203
    • Charite Universitatsmedizin Berlin KöR
  • Leipzig, Germany, 04103
    • University Hospital of Leipzig
  • Baden-Württemberg
    • Freiburg, Baden-Württemberg, Germany, 79106
      • University Medical Center Freiburg
  • Hessen
    • Darmstadt, Hessen, Germany, 64283
      • Klinikum Darmstadt
  • Niedersachsen
    • Göttingen, Niedersachsen, Germany, 37075
      • Universitatsmedizin Gottingen
  • Nordrhein-Westfalen
    • Münster, Nordrhein-Westfalen, Germany, 48145
      • St. Franziskus Hospital Munster
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Universitätsmedizin Mainz
• Hong Kong
  • Aberdeen, Hong Kong, 000000
    • The University of Hong Kong - Department of Ophthalmology
  • Shatin, New Territories, Hong Kong, 000000
    • Prince of Wales Hospital - Department of Ophthalmology and Visual Sciences
• Hungary
  • Budapest, Hungary, 1076
    • Péterfy Kórház-Rendelintézet és Manninger Jen Országos Traumatológiai Intézet - Szemészeti Osztály
  • Budapest, Hungary, 1106
    • Bajcsy-Zsilinszky Kórház és Rendelintézet
  • Budapest, Hungary, 1133
    • Budapest Retina Intezet
  • Budapest, Hungary, H-1062
    • Mh Egészségügyi Központ
  • Budapest, Hungary, H-1083
    • Semmelweis Egyetem
  • Baranya
    • Pécs, Baranya, Hungary, 7621
      • Ganglion Orvosi Központ
  • Csongrád
    • Szeged, Csongrád, Hungary, 6720
      • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4032
      • Debreceni Egyetem Klinikai Kozpont
• Israel
  • Rehovot, Israel, 7610001
    • Kaplan Medical Center
  • Zerifin, Israel, 7030000
    • Assaf Harofeh Medical Center
  • HaDarom
    • Be er-Sheva, HaDarom, Israel, 8410101
      • Soroka University Medical Center
    • Haifa, HaDarom, Israel, 3104802
      • Bnai Zion Medical Center
  • HaMerkaz
    • Kfar Saba, HaMerkaz, Israel, 4428164
      • Meir Medical Center
• Italy
  • Bologna, Italy, 40138
    • UO Oftalmologia Ciardella Pol. S.Orsola Malpighi AOU di Bologna
  • Milano, Italy, 20122
    • "Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, UO Oculistica Dipartimento di Chirurgia"
  • Lazio
    • Roma, Lazio, Italy, 00133
      • Fondazione PTV Policlinico Tor Vergata, UNIT Patologie Retiniche
    • Rome, Lazio, Italy, 00168
      • UOC Oculistica Fondazione PU A.Gemelli IRCCS Un.Cattolica del Sacro Cuore
  • Umbria
    • Perugia, Umbria, Italy, 06129
      • Università degli Studi di Perugia, Ospedale Santa Maria della Misericordia, Clinica Oculistica
• Japan
  • Akita, Japan, 010-8543
    • Akita University Hospital - Ophthalmology
  • Nagasaki, Japan, 852-8501
    • Nagasaki University Hospital - Ophthalmology
  • Aiti
    • Nagoya, Aiti, Japan, 466-8560
      • Nagoya University Hospital
    • Nagoya, Aiti, Japan, 467-8602
      • Nagoya City University Hospital - Ophthalmology
    • Nagoya, Aiti, Japan
      • Nagoya University Hospital
  • Hokkaidô
    • Asahikawa, Hokkaidô, Japan, 078-8510
      • Asahikawa Medical University Hospital
  • Hukusima
    • Fukushima, Hukusima, Japan, 960-1295
      • Fukushima Medical University Hospital - Ophthalmology
  • Kagosima
    • Kagoshima, Kagosima, Japan, 890-8520
      • Kagoshima University Hospital - Ophthalmology
  • Mie
    • Tsu, Mie, Japan, 514-8507
      • Mie University Hospital
  • Tôkyô
    • Tokyo, Tôkyô, Japan, 101-8309
      • Nihon University Hospital - Ophthalmology
  • Yamanasi
    • Chuo, Yamanasi, Japan, 409-3898
      • University of Yamanashi Hospital
  • Ôsaka
    • Hirakata, Ôsaka, Japan, 573-1191
      • Kansai Medical University Hospital - Ophthalmology
• Korea, Republic of
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital - Ophthalmology
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05505
      • Asan Medical Center
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
      • Samsung Medical Center - Ophthalmology
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06591
      • The Catholic University of Korea, Seoul St. Mary's Hospital - Neurology
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 3080
      • Seoul National University Hospital - Department of Ophthalmology
• Latvia
  • Jelgava, Latvia, LV- 3001
    • Signes Ozolinas Doctor Praxis in Ophthalmology
  • Rga
    • Riga, Rga, Latvia, 1002
      • P.Stradina Clinical University Hospital
• Lithuania
  • Klaipdos Apskritis
    • Klaipeda, Klaipdos Apskritis, Lithuania, LT-92288
      • Klaipedos Universitetine ligoniene
  • Vilniaus Apskritis
    • Vilnius, Vilniaus Apskritis, Lithuania, 8661
      • Vilniaus Universiteto Ligonines Santariskiu Klinikos (VULSK)
• Mexico
  • Zapopan, Mexico, 45116
    • Centro de Retina Medica y Quirurgica S.C.
  • Distrito Federal
    • México DF, Distrito Federal, Mexico, 04030
      • Asociación para Evitar la Ceguera en México I.A.P.
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64710
      • Centro Medico Zambrano Hellion
• Poland
  • Krakow, Poland, 31-411
    • Centrum Medyczne Promed
  • Olsztyn, Poland, 10-424
    • Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.
  • Tarnow, Poland, 33-100
    • Centrum Medyczne UNO-MED
  • Pomorskie
    • Gdansk, Pomorskie, Poland, 80-809
      • Profesorskie Centrum Okulistyki OKULISTYKA OPTIMUM
  • Wielkopolskie
    • Poznan, Wielkopolskie, Poland, 61-144
      • Szpital Sw. Wojciecha
  • Ódzkie
    • Lodz, Ódzkie, Poland, 91-134
      • Klinika Okulistyczna "Jasne Blonia"
• Serbia
  • Belgrade, Serbia, 11000
    • Clinical Center of Serbia
• Slovakia
  • Bratislavský Kraj
    • Bratislava, Bratislavský Kraj, Slovakia, 851 07
      • Univerzitna nemocnica Bratislava
  • Ilinský Kraj
    • Zilina, Ilinský Kraj, Slovakia, 012 07
      • Fakultna nemocnica s poliklinikou Zilina
  • Treniansky Kraj
    • Trencin, Treniansky Kraj, Slovakia, 911 71
      • Fakultna nemocnica Trencin
• Spain
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Valencia, Spain, 46015
    • FISABIO - Oftalmología Médica
  • Barcelona
    • LHospitalet de Llobregat, Barcelona, Spain, 8097
      • Hospital Universitario de Bellvitge
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85020
      • Associated Retina Consultants, Ltd. - Research
  • California
    • Fullerton, California, United States, 92835
      • Retina Consultants of Orange County
    • La Jolla, California, United States, 92093
      • UCSD Shiley Eye Institute, Jacobs Retina Center
    • Los Angeles, California, United States, 90095-7000
      • Jules Stein Eye Institute, UCLA
    • Palm Desert, California, United States, 92211
      • Southern California Desert Retina Consultants
    • Poway, California, United States, 92064
      • Retina Consultants San Diego
    • Redlands, California, United States, 92374
      • Retina Consultants of Southern California
    • Sacramento, California, United States, 95825
      • Retinal Consultants Medical Group, Inc.
    • Santa Ana, California, United States, 92705
      • Orange County Retina Medical Group
    • Ventura, California, United States, 93003
      • Miramar Eye Specialists
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Colorado Retina Associates
  • Connecticut
    • Waterford, Connecticut, United States, 06385
      • Retina Group of New England
  • Florida
    • Lakeland, Florida, United States, 33805
      • Florida Retina Consultants
    • Miami, Florida, United States, 33143
      • MedEye Associates
    • Winter Haven, Florida, United States, 33880
      • Center for Retina and Macular Disease
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Southeast Retina Center
    • Marietta, Georgia, United States, 30060
      • Georgia Retina, P.C.
  • Illinois
    • Elmhurst, Illinois, United States, 60126
      • Retina Associates IL
  • Kansas
    • Leawood, Kansas, United States, 66211
      • Sabates Eye Center
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Retina Associates New Orleans
  • Maryland
    • Baltimore, Maryland, United States, 21209
      • The Retina Care Center
  • Michigan
    • Jackson, Michigan, United States, 49202
      • Specialty Eye Institute
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55416
      • Retina Center
  • New York
    • Liverpool, New York, United States, 13088
      • Retina Vitreous Surgeons of Central NY, PC
    • New York, New York, United States, 10021
      • Macula Care
    • Troy, New York, United States, 12180
      • Ophthalmic Consultants of the Capital Region - Ophthalmology
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Charlotte Eye Ear Nose & Throat Associates, P.A.
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Sterling Research Group
  • Pennsylvania
    • Kingston, Pennsylvania, United States, 18704
      • Eye Care Specialists
  • South Carolina
    • Ladson, South Carolina, United States, 29456
      • Charleston Neuroscience Institute
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Regional Eye Institute - Ophthalmology
  • Texas
    • Abilene, Texas, United States, 79606
      • Retina Research Institute of Texas
    • Bellaire, Texas, United States, 77401
      • Retina Consultants of Texas Research Centers
    • Dallas, Texas, United States, 75231
      • Texas Retina Associates
    • Fort Worth, Texas, United States, 76102
      • Ophthalmology Associates
    • Fort Worth, Texas, United States, 76012
      • Texas Retina Associates
    • Fort Worth, Texas, United States, 76014
      • Texas Retina Associates
    • Midland, Texas, United States, 79706
      • Premiere Retina Specialists
    • San Antonio, Texas, United States, 78240-1375
      • Retina Associates of South Texas, P.A.
    • The Woodlands, Texas, United States, 77384
      • Retina Consultants of Houston
    • Willow Park, Texas, United States, 76087
      • Strategic Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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
Active Comparator: 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.	Drug: 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 Names: Eylea®
Active Comparator: 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	Drug: 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; Drug: 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 Names: Eylea®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 52
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.	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	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.	Week 8
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.	Week 52
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.	Baseline and Weeks 8, 16, 24, and 52
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.	Baseline and Weeks 4, 8, 16, 24, 32, 40, 48, and 52
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.	Up to Week 52
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.	Baseline up to Week 52

Collaborators and Investigators

• Sponsor: Amgen
• Collaborators: Parexel
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2020
• Primary Completion (Actual): July 18, 2022
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: 20170542; 2019-002503-17 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No