[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07614776":3,"trial-entities:NCT07614776":406,"trial-summary:NCT07614776":410},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":46,"secondary_outcomes":50,"sex":93,"minimum_age":94,"maximum_age":17,"healthy_volunteers":95,"eligibility_criteria":96,"std_ages":117,"locations":120,"central_contacts":391,"overall_officials":397,"references":401,"see_also_links":402},"NCT07614776","20250115","A Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA® HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration","A Randomized, Double-masked, Comparative Clinical Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 938 8 mg Versus EYLEA® HD (Aflibercept) Delivered Via Intravitreal Injection in Participants With Neovascular Age-related Macular Degeneration","RECRUITING","2028-01-12","2026-07","2026-07-28","2026-05-27","Amgen","INDUSTRY",true,"The aim of this trial is to demonstrate similarity in efficacy between ABP 938 8 mg and aflibercept (US) 8 mg by evaluating the change in best corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (nAMD)",null,[19,20],"Neovascular Age-related Macular Degeneration","nAMD",[22,23,24,25,26,27],"ABP 938","Aflibercept","neovascular age-related macular degeneration","Intravitreal","Randomized Controlled Trial","Double-masked","INTERVENTIONAL","TREATMENT",[31],"PHASE3",{"count":33,"type":34},304,"ESTIMATED",[36,41],{"type":37,"name":38,"description":39,"armGroupLabels":40},"DRUG","ABP 938 8 mg","IVT injection",[38],{"type":37,"name":42,"description":39,"armGroupLabels":43,"otherNames":44},"Aflibercept (US) 8 mg",[42],[45],"EYLEA HD",[47],{"measure":48,"timeFrame":49},"Change From Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score","Baseline and Week 12",[51,54,57,60,62,64,66,69,71,74,76,78,80,82,85,88,91],{"measure":52,"timeFrame":53},"Percentage of Participants With Absence of Intraretinal Fluid (IRF) and Subretinal Fluid (SRF) in the Center Subfield, as Assessed by Spectral-Domain Optical Coherence Tomography (SD-OCT)","Week 16",{"measure":55,"timeFrame":56},"Change from Baseline in BCVA as measured by ETDRS letter score","Baseline to Week 48",{"measure":58,"timeFrame":59},"Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 24","Baseline to Week 24",{"measure":61,"timeFrame":56},"Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 48",{"measure":63,"timeFrame":56},"Change From Baseline in Choroidal Neovascularization (CNV) Area Size as Measured by Fluorescein Angiography (FA)",{"measure":65,"timeFrame":56},"Change From Baseline in Central Subfield Thickness (CST) as Measured by SD-OCT",{"measure":67,"timeFrame":68},"Percentage of Participants Who Met Protocol-Defined DRA Criteria, as Determined by Protocol-Specified Clinical and Imaging Assessments","Week 16 and Week 20",{"measure":67,"timeFrame":70},"Week 48",{"measure":72,"timeFrame":73},"Number of Participants Who Experienced Ocular Treatment-Emergent Adverse Events (TEAEs)","Baseline up to Week 48",{"measure":75,"timeFrame":73},"Number of Participants Who Experienced Non-Ocular TEAEs",{"measure":77,"timeFrame":73},"Number of Participants Who Experienced Treatment-Emergent Events of Interest (EOI)",{"measure":79,"timeFrame":73},"Number of Participants Who Experienced Treatment-Emergent Serious Adverse Events (TESAEs)",{"measure":81,"timeFrame":73},"Number of Participants Who Developed Binding Antidrug Antibodies (ADAs)",{"measure":83,"timeFrame":84},"Free serum concentrations of ABP 938 8 mg","Week 16, week 24 and 48 (End of Study)",{"measure":86,"timeFrame":87},"Free serum concentrations of Aflibercept (US) 8 mg","Week 16, week 24, and 48 (End of Study)",{"measure":89,"timeFrame":90},"Pharmacokinetic (PK) parameters of ABP 938 8mg derived from concentration - time profiles following the first dose in a PK substudy","From Baseline (day 1, week 0) to Day 29 (pre dose week 4)",{"measure":92,"timeFrame":90},"Pharmacokinetic parameters of Aflibercept (US) 8 mg derived from concentration - time profiles following the first dose in a PK substudy","ALL","50 Years",false,{"inclusion":97,"exclusion":103,"raw_text":116},[98,99,100,101,102],"Men or women ≥ 50 years old, capable of giving signed informed consent","Active, treatment-naïve subfoveal CNV lesions secondary to nAMD including juxtafoveal lesions that affect the fovea as confirmed by SD-OCT and FA in the study eye (SE)","Total area of CNV (including both classic and occult components) \\> 50% of the total lesion area in the SE","The BCVA letter score ≥ 24 and ≤ 78 letters, in the SE","Presence of intra and\u002For subretinal fluid affecting the central subfield of the SE as identified by SD-OCT attributable to active CNV. The central subfield is defined as a circle with a diameter of 1 mm, centered on the fovea",[104,105,106,107,108,109,110,111,112,113,114,115],"Total lesion size \\> 12 disc areas (30.5 mm2) including blood, scars, and neovascularization, in the study eye","Scar, fibrosis, or atrophy involving the central subfield in the study eye","Scar or fibrosis involving \\> 50% of the total lesion in the study eye","Presence of retinal pigment epithelium tears or rips involving the macula in the study eye","History of any vitreous hemorrhage ≤ 4 weeks (28 days) before randomization in the study","Presence of other causes of CNV, including pathologic myopia (spherical equivalent ≥ 8 diopters negative or axial length ≥ 25 mm), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study","Uncontrolled glaucoma (defined as IOP \\>25 mmHg despite treatment with anti-glaucoma medication) in the study eye","History or clinical evidence of DR, DME, idiopathic autoimmune uveitis, or any other vascular disease affecting the retina, other than nAMD in either eye","Evidence of active extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening or randomization","Uncontrolled blood pressure (defined as systolic \\>160 mmHg or diastolic \\>95 mmHg). Blood pressure needs to be stable for at least 12 weeks (84 days) prior to screening","Any prior or concomitant ocular or systemic treatment (with an investigational or approved, anti VEGF or anti-VEGF\u002Fanti-angiopoietin agent) in the SE, or surgery for nAMD in the SE, except dietary supplements or vitamins","History or evidence of any other clinically significant disorder, condition, disease or clinical laboratory abnormality that, in the opinion of the investigator or study medical monitor, if consulted, would pose a risk to participant safety or interfere with the study evaluation or results interpretation","Inclusion Criteria:\n\n* Men or women ≥ 50 years old, capable of giving signed informed consent\n* Active, treatment-naïve subfoveal CNV lesions secondary to nAMD including juxtafoveal lesions that affect the fovea as confirmed by SD-OCT and FA in the study eye (SE)\n* Total area of CNV (including both classic and occult components) \\> 50% of the total lesion area in the SE\n* The BCVA letter score ≥ 24 and ≤ 78 letters, in the SE\n* Presence of intra and\u002For subretinal fluid affecting the central subfield of the SE as identified by SD-OCT attributable to active CNV. The central subfield is defined as a circle with a diameter of 1 mm, centered on the fovea\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply at either screening or baseline, unless otherwise indicated per protocol:\n\n* Total lesion size \\> 12 disc areas (30.5 mm2) including blood, scars, and neovascularization, in the study eye\n* Scar, fibrosis, or atrophy involving the central subfield in the study eye\n* Scar or fibrosis involving \\> 50% of the total lesion in the study eye\n* Presence of retinal pigment epithelium tears or rips involving the macula in the study eye\n* History of any vitreous hemorrhage ≤ 4 weeks (28 days) before randomization in the study\n* Presence of other causes of CNV, including pathologic myopia (spherical equivalent ≥ 8 diopters negative or axial length ≥ 25 mm), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study\n* Uncontrolled glaucoma (defined as IOP \\>25 mmHg despite treatment with anti-glaucoma medication) in the study eye\n* History or clinical evidence of DR, DME, idiopathic autoimmune uveitis, or any other vascular disease affecting the retina, other than nAMD in either eye\n* Evidence of active extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening or randomization\n* Uncontrolled blood pressure (defined as systolic \\>160 mmHg or diastolic \\>95 mmHg). Blood pressure needs to be stable for at least 12 weeks (84 days) prior to screening\n* Any prior or concomitant ocular or systemic treatment (with an investigational or approved, anti VEGF or anti-VEGF\u002Fanti-angiopoietin agent) in the SE, or surgery for nAMD in the SE, except dietary supplements or vitamins\n* History or evidence of any other clinically significant disorder, condition, disease or clinical laboratory abnormality that, in the opinion of the investigator or study medical monitor, if consulted, would pose a risk to participant safety or interfere with the study evaluation or results interpretation\n* Other protocol-specified exclusion criteria",[118,119],"ADULT","OLDER_ADULT",[121,130,137,144,151,158,165,173,181,189,196,203,211,219,227,234,242,250,258,266,274,282,290,297,304,311,317,325,332,339,346,353,360,368,376,384],{"facility":122,"status":8,"city":123,"state":124,"zip":125,"country":126,"geoPoint":127},"Retina Consultants of Orange County","Fullerton","California","92835-3432","United States",{"lat":128,"lon":129},33.87029,-117.92534,{"facility":131,"status":8,"city":132,"state":124,"zip":133,"country":126,"geoPoint":134},"South Coast Retina Center - RCA","Long Beach","90607",{"lat":135,"lon":136},33.76696,-118.18923,{"facility":138,"status":8,"city":139,"state":124,"zip":140,"country":126,"geoPoint":141},"Retinal Consultants Medical Group, Inc.-Sacramento, Greenback Lane, (RCA)","Modesto","95356",{"lat":142,"lon":143},37.6391,-120.99688,{"facility":145,"status":8,"city":146,"state":124,"zip":147,"country":126,"geoPoint":148},"California Eye Specialists Medical Group, Inc","Pasadena","91107",{"lat":149,"lon":150},34.14778,-118.14452,{"facility":152,"status":8,"city":153,"state":124,"zip":154,"country":126,"geoPoint":155},"Retinal Consultants Medical Group, Inc - Sacramento - Parkcenter Drive (RCA)","Sacramento","95825",{"lat":156,"lon":157},38.58157,-121.4944,{"facility":159,"status":8,"city":160,"state":124,"zip":161,"country":126,"geoPoint":162},"California Retina Consultants","Santa Barbara","93103",{"lat":163,"lon":164},34.42083,-119.69819,{"facility":166,"status":8,"city":167,"state":168,"zip":169,"country":126,"geoPoint":170},"Retina Consultants of Southern Colorado (Colorado Springs)- RCA","Colorado Springs","Colorado","80909-1183",{"lat":171,"lon":172},38.83388,-104.82136,{"facility":174,"status":8,"city":175,"state":176,"zip":177,"country":126,"geoPoint":178},"Retina Group of New England","Waterford","Connecticut","06385",{"lat":179,"lon":180},41.3417,-72.13597,{"facility":182,"status":8,"city":183,"state":184,"zip":185,"country":126,"geoPoint":186},"Medeye Associates - Research","Miami","Florida","33143",{"lat":187,"lon":188},25.77427,-80.19366,{"facility":190,"status":8,"city":191,"state":184,"zip":192,"country":126,"geoPoint":193},"Retina Consultants of Southwest Florida - Naples","Naples","34103-4457",{"lat":194,"lon":195},26.14234,-81.79596,{"facility":197,"status":8,"city":198,"state":184,"zip":199,"country":126,"geoPoint":200},"Advanced Research, LLC","Pensacola","32503",{"lat":201,"lon":202},30.42131,-87.21691,{"facility":204,"status":8,"city":205,"state":206,"zip":207,"country":126,"geoPoint":208},"Retina Associates","Elmhurst","Illinois","60126",{"lat":209,"lon":210},41.89947,-87.94034,{"facility":212,"status":8,"city":213,"state":214,"zip":215,"country":126,"geoPoint":216},"Associated Vitreoretinal and Uveitis Consultants","Carmel","Indiana","46032",{"lat":217,"lon":218},39.97837,-86.11804,{"facility":220,"status":8,"city":221,"state":222,"zip":223,"country":126,"geoPoint":224},"Mid Atlantic Retina Specialists","Hagerstown","Maryland","21740-5846",{"lat":225,"lon":226},39.64176,-77.71999,{"facility":228,"status":8,"city":229,"state":222,"zip":230,"country":126,"geoPoint":231},"Retina Specialists","Towson","21204",{"lat":232,"lon":233},39.4015,-76.60191,{"facility":235,"status":8,"city":236,"state":237,"zip":238,"country":126,"geoPoint":239},"Retina Consultants of Minnesota","Edina","Minnesota","55435",{"lat":240,"lon":241},44.88969,-93.34995,{"facility":243,"status":8,"city":244,"state":245,"zip":246,"country":126,"geoPoint":247},"Mississippi Retina Assoc","Madison","Mississippi","39110",{"lat":248,"lon":249},32.46181,-90.11536,{"facility":251,"status":8,"city":252,"state":253,"zip":254,"country":126,"geoPoint":255},"The Retina Institute, Research Retina Institute (RCA)","St Louis","Missouri","63128",{"lat":256,"lon":257},38.62727,-90.19789,{"facility":259,"status":8,"city":260,"state":261,"zip":262,"country":126,"geoPoint":263},"Vision Research Center Eye Associates of New Mexico","Albuquerque","New Mexico","87109",{"lat":264,"lon":265},35.08449,-106.65114,{"facility":267,"status":8,"city":268,"state":269,"zip":270,"country":126,"geoPoint":271},"Ophthalmic Consultants of Long Island - Research","Oceanside","New York","11572",{"lat":272,"lon":273},40.63871,-73.64013,{"facility":275,"status":8,"city":276,"state":277,"zip":278,"country":126,"geoPoint":279},"NC Retina Associates-RCA","Wake Forest","North Carolina","27587",{"lat":280,"lon":281},35.97987,-78.50972,{"facility":283,"status":8,"city":284,"state":285,"zip":286,"country":126,"geoPoint":287},"Retina Consultants of South Carolina, Charleston Neuroscience institute - Blufffon (RCA)","Beaufort","South Carolina","29902",{"lat":288,"lon":289},32.4317,-80.66993,{"facility":291,"status":8,"city":292,"state":285,"zip":293,"country":126,"geoPoint":294},"Charleston Neuroscience Institute","Charleston","29414-5896",{"lat":295,"lon":296},32.77632,-79.93275,{"facility":298,"status":8,"city":299,"state":285,"zip":300,"country":126,"geoPoint":301},"Palmetto Retina Center - Main (RCA)","Columbia","29169",{"lat":302,"lon":303},34.00071,-81.03481,{"facility":305,"status":8,"city":306,"state":285,"zip":307,"country":126,"geoPoint":308},"Retina Consultants of South Carolina, Charleston Neuroscience Institute- Ladson (RCA)","Ladson","29456",{"lat":309,"lon":310},32.98573,-80.10981,{"facility":312,"status":8,"city":313,"state":285,"zip":300,"country":126,"geoPoint":314},"Palmetto Retina Center, Florence (RCA)","West Columbia",{"lat":315,"lon":316},33.99349,-81.07398,{"facility":318,"status":8,"city":319,"state":320,"zip":321,"country":126,"geoPoint":322},"Texas Retina Associates (TRA) - Arlington","Arlington","Texas","76012",{"lat":323,"lon":324},32.73569,-97.10807,{"facility":326,"status":8,"city":327,"state":320,"zip":328,"country":126,"geoPoint":329},"Austin Retina Associates - Ophthalmology\u002FRetina","Austin","78705",{"lat":330,"lon":331},30.26715,-97.74306,{"facility":333,"status":8,"city":334,"state":320,"zip":335,"country":126,"geoPoint":336},"Texas Retina Associates (TRA) - Dallas Main","Dallas","75231",{"lat":337,"lon":338},32.78306,-96.80667,{"facility":340,"status":8,"city":341,"state":320,"zip":342,"country":126,"geoPoint":343},"Texas Retina Associates - Fort Worth","Fort Worth","76104",{"lat":344,"lon":345},32.72541,-97.32085,{"facility":347,"status":8,"city":348,"state":320,"zip":349,"country":126,"geoPoint":350},"Retina Consultants of Texas - Katy Retina Center","Houston","77401",{"lat":351,"lon":352},29.76328,-95.36327,{"facility":354,"status":8,"city":355,"state":320,"zip":356,"country":126,"geoPoint":357},"Retina Consultants of Texas - Schertz","Schertz","78154",{"lat":358,"lon":359},29.55217,-98.26973,{"facility":361,"status":8,"city":362,"state":363,"zip":364,"country":126,"geoPoint":365},"Retina Associates of Utah - Retina Specialist","Salt Lake City","Utah","84107",{"lat":366,"lon":367},40.76078,-111.89105,{"facility":369,"status":8,"city":370,"state":371,"zip":372,"country":126,"geoPoint":373},"Emerson Clinical Research- Virginia Retina Specialists","Falls Church","Virginia","22042-2349",{"lat":374,"lon":375},38.88233,-77.17109,{"facility":377,"status":8,"city":378,"state":379,"zip":380,"country":126,"geoPoint":381},"Vitreoretinal Associates of Washington","Bellevue","Washington","98004-3779",{"lat":382,"lon":383},47.61038,-122.20068,{"facility":385,"status":8,"city":386,"state":379,"zip":387,"country":126,"geoPoint":388},"Retina Center NW PLLC","Silverdale","98383",{"lat":389,"lon":390},47.64454,-122.69487,[392],{"name":393,"role":394,"phone":395,"email":396},"Amgen Call Center","CONTACT","866-572-6436","medinfo@amgen.com",[398],{"name":399,"affiliation":13,"role":400},"MD","STUDY_DIRECTOR",[],[403],{"label":404,"url":405},"AmgenTrials clinical trials website","http:\u002F\u002Fwww.amgentrials.com",{"nct_id":4,"conditions":407,"biomarkers":409},[408],"Exudative age-related macular degeneration",[],{"nct_id":4,"found":95,"summary":17,"prompt_version":17}]