NCT07614776RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 304 (estimated)
- First submitted
- 22 May 2026
- Start date
- 27 May 2026
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Amgen
- Diseases
- Macular degeneration
- NCT number
- NCT07614776
- EU CT number
- 2025-523500-72-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 304
- From 27 May 2026 to the primary completion date, 31 Jul 2027
- 108 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Uncontrolled glaucoma (defined as IOP \>25 mmHg despite treatment with anti-glaucoma medication) in the study eye
- 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/anti-angiopoietin agent) in the SE, or surgery for nAMD in the SE, except dietary supplements or vitamins
Other illness
- 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
- 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
Lab values
- 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
Other
- Participants are excluded from the study if any of the following criteria apply at either screening or baseline, unless otherwise indicated per protocol:
- 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
- Other protocol-specified exclusion criteria
Who the study is looking for
- 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/or 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
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (108)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje Coordinator of this site? Confirm its status | Mladá Boleslav | Czechia | Recruiting |
| VISUS, spol s.r.o. Coordinator of this site? Confirm its status | Náchod | Czechia | Recruiting |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Recruiting |
| Oftex s.r.o. Coordinator of this site? Confirm its status | Pardubice V | Czechia | Recruiting |
| Fakultni Nemocnice Plzen Coordinator of this site? Confirm its status | Plzen 23 | Czechia | Recruiting |
| Fakultni nemocnice Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Axon Clinical s.r.o. Coordinator of this site? Confirm its status | Prague 5 | Czechia | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Centro De Oftalmologia Barraquer S.A. Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital La Luz Grupo Quironsalud Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Hospital Universitari General de Catalunya Coordinator of this site? Confirm its status | Sant Cugat del Vallès | Spain | Recruiting |
| Hospital Provincial de Conxo Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Central Hospital Of Northern Pest Military Hospital Coordinator of this site? Confirm its status | Budapest VI | Hungary | Recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest VIII | Hungary | Recruiting |
| Budapest Retina Associates Kft. Coordinator of this site? Confirm its status | Budapest XIII | Hungary | Recruiting |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Recruiting |
| Nozologen Kft. Coordinator of this site? Confirm its status | Pécs | Hungary | Recruiting |
| University of Pecs Coordinator of this site? Confirm its status | Pécs | Hungary | Recruiting |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Recruiting |
| Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz Coordinator of this site? Confirm its status | Szombathely | Hungary | Recruiting |
| Zala Varmegyei Szent Rafael Korhaz Coordinator of this site? Confirm its status | Zalaegerszeg | Hungary | Recruiting |
| Tokyo Medical Center - Ophthalmology Coordinator of this site? Confirm its status | Meguro-ku | Japan | Recruiting |
| SUGITA EYE HOSPITAL - Ophthalmology Coordinator of this site? Confirm its status | Nagoya | Japan | Recruiting |
| Nihon University Hospital - Ophthalmology Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Tokushima University Hospital - Ophthalmology Coordinator of this site? Confirm its status | Ube | Japan | Recruiting |
| Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Coordinator of this site? Confirm its status | Kaunas | Lithuania | Recruiting |
| Vilniaus universiteto ligonine Santaros klinikos VšĮ Coordinator of this site? Confirm its status | Vilnius | Lithuania | Recruiting |
| Latvijas Amerikas Acu Centrs SIA Coordinator of this site? Confirm its status | Riga | Latvia | Recruiting |
| Riga East University Hospital - Department of Ophthalmology, Clinical Center "Bikernieki" Coordinator of this site? Confirm its status | Riga | Latvia | Recruiting |
| Pauls Stradins Clinical University Hospital Coordinator of this site? Confirm its status | Riga | Latvia | Recruiting |
| Ziemelkurzemes regionala slimnica SIA Coordinator of this site? Confirm its status | Ventspils | Latvia | Recruiting |
| OFTALMIKA Sp. z o.o Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Szpital Sw. Rozy Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Como Centrum Okulistyki Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Santa SP. z o.o Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o. Coordinator of this site? Confirm its status | Olsztyn | Poland | Recruiting |
| Ośrodek Chirurgii Oka Prof. Zagórskiego Sp. Z o.o. Coordinator of this site? Confirm its status | Rzeszów | Poland | Recruiting |
| Caminomed Sp. z o.o. Coordinator of this site? Confirm its status | Tarnowskie Góry | Poland | Recruiting |
| Warszawski Szpital Okulistyczny Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| F D Roosevelt University General Hospital Of Banska Bystrica Coordinator of this site? Confirm its status | Banska Bystrica | Slovakia | Recruiting |
| Robin Look spol. s r.o. Coordinator of this site? Confirm its status | Bratislava | Slovakia | Recruiting |
| University Hospital Bratislava Coordinator of this site? Confirm its status | Bratislava | Slovakia | Recruiting |
| Fakultna Nemocnica Nitra Coordinator of this site? Confirm its status | Nitra | Slovakia | Recruiting |
| Euromedix a.s. Coordinator of this site? Confirm its status | Petrzalka | Slovakia | Recruiting |
| Nemocnica Poprad, a.s. Coordinator of this site? Confirm its status | Poprad | Slovakia | Recruiting |
| Univerzitna nemocnica Nemocnica svaeteho Michala a.s. Coordinator of this site? Confirm its status | Stare Mesto | Slovakia | Recruiting |
| Nemocnica s poliklinikou Trebisov a.s. Coordinator of this site? Confirm its status | Trebišov | Slovakia | Recruiting |
| Fakultna nemocnica Trencin Coordinator of this site? Confirm its status | Trenčín | Slovakia | Recruiting |
| Fakultna nemocnica s poliklinikou Zilina Coordinator of this site? Confirm its status | Žilina | Slovakia | Recruiting |
| Vision Research Center Eye Associates of New Mexico Coordinator of this site? Confirm its status | Albuquerque | United States | Recruiting |
| Texas Retina Associates (TRA) - Arlington Coordinator of this site? Confirm its status | Arlington | United States | Recruiting |
| Austin Retina Associates Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Austin Retina Associates Ophthalmology/Retina Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| The Retina Care Center- Baltimore (PRISM Vision Group) Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Retina Consultants of South Carolina, Charleston Neuroscience institute - Blufffon (RCA) Coordinator of this site? Confirm its status | Beaufort | United States | Recruiting |
| Retina Consultants of Texas (Bellaire) Coordinator of this site? Confirm its status | Bellaire | United States | Recruiting |
| Vitreoretinal Associates of Washington Coordinator of this site? Confirm its status | Bellevue | United States | Recruiting |
| Envision Ocular, LLC Coordinator of this site? Confirm its status | Bloomfield | United States | Recruiting |
| Ophthalmic Consultants of Boston Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Associated Vitreoretinal and Uveitis Consultants Coordinator of this site? Confirm its status | Carmel | United States | Recruiting |
| Charleston Neuroscience Institute Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| University Retina - Bedford Park Location Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Retina Consultants of Southern Colorado (Pueblo)- RCA Coordinator of this site? Confirm its status | Colorado Springs | United States | Recruiting |
| Retina Consultants of Southern Colorado (Colorado Springs)- RCA Coordinator of this site? Confirm its status | Colorado Springs | United States | Recruiting |
| Palmetto Retina Center - Main (RCA) Coordinator of this site? Confirm its status | Columbia | United States | Recruiting |
| Texas Retina Associates (Tra) - Dallas Main Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Midwest Retina - Main Office Coordinator of this site? Confirm its status | Dublin | United States | Recruiting |
| Retina Consultants of Minnesota (RCM) - St. Louis Park Coordinator of this site? Confirm its status | Edina | United States | Recruiting |
| Retina Associates Coordinator of this site? Confirm its status | Elmhurst | United States | Recruiting |
| Emerson Clinical Research- Virginia Retina Specialists Coordinator of this site? Confirm its status | Falls Church | United States | Recruiting |
| Texas Retina Associates - Fort Worth Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| Retina Consultants of Orange County Coordinator of this site? Confirm its status | Fullerton | United States | Recruiting |
| Mid Atlantic Retina Specialists Coordinator of this site? Confirm its status | Hagerstown | United States | Recruiting |
| Retina Consultants of Texas - Katy Retina Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Retina Consultants of Texas - The Woodlands Coordinator of this site? Confirm its status | Katy | United States | Recruiting |
| Eye Care Specialists - Kingston Coordinator of this site? Confirm its status | Kingston | United States | Recruiting |
| Retina Consultants of South Carolina, Charleston Neuroscience Institute- Ladson (RCA) Coordinator of this site? Confirm its status | Ladson | United States | Recruiting |
| Colorado Retina Associates (RCA) Coordinator of this site? Confirm its status | Lakewood | United States | Recruiting |
| Retina Vitreous Surgeons of CNY, PC Coordinator of this site? Confirm its status | Liverpool | United States | Recruiting |
| South Coast Retina Center - RCA Coordinator of this site? Confirm its status | Long Beach | United States | Recruiting |
| Mississippi Retina Assoc Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
| Medeye Associates - Research Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Retinal Consultants Medical Group, Inc - Modesto (RCA) Coordinator of this site? Confirm its status | Modesto | United States | Recruiting |
| Retina Consultants of South Carolina, Charleston Neuroscience Institute- Mount Pleasant (RCA) Coordinator of this site? Confirm its status | Mt. Pleasant | United States | Recruiting |
| Retina Consultants of Southwest Florida - Naples Coordinator of this site? Confirm its status | Naples | United States | Recruiting |
| Tennessee Retina, PC Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Ophthalmic Consultants of Long Island - Research Coordinator of this site? Confirm its status | Oceanside | United States | Recruiting |
| California Eye Specialists Medical Group, Inc. Coordinator of this site? Confirm its status | Pasadena | United States | Recruiting |
| Advanced Research, LLC Coordinator of this site? Confirm its status | Pensacola | United States | Recruiting |
| North Carolina Retina Associates Coordinator of this site? Confirm its status | Raleigh | United States | Recruiting |
| Retinal Consultants Medical Group, Inc - Sacramento - Parkcenter Drive (RCA) Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| Retina Associates Of Utah Retina Specialist Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| Retinal Consultants of Texas- San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| California Retina Consultants Coordinator of this site? Confirm its status | Santa Barbara | United States | Recruiting |
| Long Island Vitreoretinal Consultants(RCA Network) Coordinator of this site? Confirm its status | Scarsdale | United States | Recruiting |
| Retina Consultants of Texas - Schertz Coordinator of this site? Confirm its status | Schertz | United States | Recruiting |
| Retina Center NW PLLC Coordinator of this site? Confirm its status | Silverdale | United States | Recruiting |
| Spokane Eye Clinic (OCT and optical exam Coordinator of this site? Confirm its status | Spokane | United States | Recruiting |
| The Retina Institute, Research Retina Institute (RCA) Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Retina Specialists Coordinator of this site? Confirm its status | Towson | United States | Recruiting |
| NC Retina Associates- RCA Coordinator of this site? Confirm its status | Wake Forest | United States | Recruiting |
| Retina Group of New England Coordinator of this site? Confirm its status | Waterford | United States | Recruiting |
| Palmetto Retina Center, Florence (RCA) Coordinator of this site? Confirm its status | West Columbia | United States | Recruiting |
| Strategic Clinical Research Group, LLC Coordinator of this site? Confirm its status | Willow Park | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.