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]

Completed · Phase 3

Conditions studied: Neovascular (Wet) Age-related Macular Degeneration (AMD)

In brief

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.

Key facts

Study ID: NCT04270747
Run by: Amgen
People needed: 576
Starts: 2020-06-22
Expected to finish: 2023-01-30
Last updated by the study team: 2025-09-10

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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
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

Where it is running

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
Associated Retina Consultants, Ltd. - Research — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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